QUICKANCHOR PANACRYL 212852Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705002412), received between Jan 25, 2018 and Jan 22, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K030995, 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2019Migration or Expulsion of Device; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Split, Cut or Torn

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANKLE REPAIR PROCEDURE WHEN TUGGING ON THE SUTURES ON TWO OF THE CUSTOMER'S MINILOK QUICK ANCHORS + 2-0 PCRYL WITH RB-1 TO MAKE SURE FIXATION WAS IN, THE SUTURES BROKE AND THE ANCHORS PULLED OUT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS HARD AND CONFIRMED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED. A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266467 ↗
• MalfunctionJan 22, 2019Migration or Expulsion of Device; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANKLE REPAIR PROCEDURE WHEN TUGGING ON THE SUTURES ON TWO OF THE CUSTOMER'S MINILOK QUICK ANCHORS + 2-0 PCRYL WITH RB-1 TO MAKE SURE FIXATION WAS IN, THE SUTURES BROKE AND THE ANCHORS PULLED OUT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS HARD AND CONFIRMED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED. A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT; THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266465 ↗
• MalfunctionOct 17, 2018Failure to Advance; Failure to Advance

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT TWO OF THE CUSTOMER'S MINILOK QA PLUS 2/0 WITH PANACRYL WOULD NOT SEAT IN THE BONE HOLE DURING A HAND PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO NEW BONE HOLE NEEDED TO BE CREATED. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974459 ↗
• MalfunctionJan 25, 2018Difficult To Position; Difficult To Position

  IT WAS REPORTED BY THE SALES REP THAT TWO OF THE CUSTOMER'S MINILOK QA PLUS 2/0 WITH PANACRYL WOULD NOT SEAT IN THE BONE HOLE DURING A HAND PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. NO NEW BONE HOLE NEEDED TO BE CREATED. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7219174 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030995, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• 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-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