BIOKNOTLESS PANACRYL ETHIBOND 212723Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886705002092), received between Jun 19, 2018 and Jun 14, 2023 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (29 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (K040827, K070925, K150209); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 13, 2023Class IIOpen, Classified

   IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

   Z-1681-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, IT WAS CONFIRMED FOLLOWING A REVIEW OF IMAGING THAT RETAINED METAL FRAGMENT TIPS FROM THE INTRODUCER REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17126068 ↗
• MalfunctionMay 9, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, FOLLOWING A REVIEW OF IMAGING, IT WAS CONFIRMED THAT THERE WERE METAL FRAGMENT TIPS FROM THE INTRODUCER THAT REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16897342 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY A REVIEW OF IMAGING, CONFIRMED RETAINED METAL FRAGMENT TIPS FROM THE INTRODUCER THAT REMAINED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16889682 ↗
• MalfunctionFeb 7, 2023Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE USING A ,BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE, THE PATIENT EXPERIENCED METAL FRAGMENTS MIGRATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313089 ↗
• MalfunctionFeb 7, 2023Migration; Migration

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN UNITED KINGDOM THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE USING A ,BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE, THE PATIENT EXPERIENCED METAL FRAGMENTS MIGRATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313069 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132866 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132864 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132862 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132777 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132775 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132750 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132749 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132747 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132691 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132684 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132636 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132619 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132600 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132568 ↗
• MalfunctionJan 10, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING REVIEW OF PATIENT IMAGING, IT WAS OBSERVED THAT THERE WERE RETAINED INSERTER METAL TIPS WITHIN BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE. THERE WAS NO PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16132560 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN THE UNITED KINGDOM THAT THE INTRODUCER END SNAPPING OFF INSIDE THE BIOKNOTLESS BR ANCHOR W/PANACRYL DEVICE WHEN ATTEMPTING TO DISCONNECT IT FROM THE ANCHOR TO ALLOW THE INTRODUCERS REMOVAL THAT RESULTED IN THE END OF THE INTRODUCER (METALLIC) BEING LEFT ATTACHED TO THE BIOKNOTLESS ANCHOR INSIDE THE BONE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15634288 ↗
• MalfunctionAug 10, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT WHEN A PATIENT UNDERWENT AN MRI SCAN ON AN UNKNOWN DATE, SOMETHING PING IN THE SHOULDER. ACCORDING TO THE REPORT, CT/X-RAYS REVEALED THAT THE BIOKNOTLESS BR ANCHOR W/ PANACRYL DEVICE APPEARED TO HAVE BECOME DETACHED. IT WAS FURTHER REPORTED THAT IT REVEALED WHAT LOOKS LIKE TO BE A METAL COMPONENT (OR VERY DENSE AREA) ASSOCIATED WITH THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199410 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN INSTABILITY REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BIOKNOTLESS RAPIDE W/PAN DEVICE BROKE ABOVE THE TIP. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT'S BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093275 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BIOKNOTLESS RAPIDE W/PAN DEVICE BROKE ABOVE THE TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093267 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BIOKNOTLESS RAPIDE W/PAN DEVICE BROKE ABOVE THE TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040827, K070925, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1171-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1164-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1167-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1165-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1166-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1162-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1168-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1169-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1170-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1163-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-0316-2012 · Oct 31, 2011 · Terminated
  DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate pos

…and 5 more.