BIORAPTOR 72203281Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010656469), received between Oct 24, 2017 and Jun 25, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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

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 16, 2026.

Recalls naming this device

1. Oct 29, 2024Open, Classified

   Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

   Z-0581-2025 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) BIORAPTOR SUTURE ANCHOR WAS BROKEN. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617114 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE OF THE BIORAPTOR BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION AND TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386231 ↗
• MalfunctionFeb 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REPAIR OF THE LATERAL COLLATERAL LIGAMENT OF THE ANKLE, TWO (2) BIORAPTOR ANCHORS WERE PULLED OUT. THE PROCEDURE WAS RESUMED, WITH A SIGNIFICANT DELAY, USING A KEYIBANGEN COMPETITOR DEVICE. THE DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID IN THE PATIENT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410884 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER LABRAL REPAIR, THE BIORAPTOR ANCHOR BROKE WHILE IT WAS BEING IMPLANTED. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649167 ↗
• MalfunctionMar 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A JOINT GLENOID LABRUM REPAIR SURGERY, THE BIORAPTOR ANCHOR PULLED OUT AFTER IT WAS IMPLANTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969037 ↗
• InjuryFeb 8, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A SHOULDER JOINT GLENOID LABRUM REPAIR SURGERY, THE BIORAPTOR ANCHOR WAS PULLED TOGETHER WITH THE NEEDLE. THERE WAS A 30 MINUTE SURGICAL DELAY AS A NEW BONE HOLE WAS DRILLED TO PLACE THE BACKUP DEVICE. A VOID BONE HOLE WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479850 ↗
• InjuryDec 29, 2021Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A DISLOCATION OF SHOULDER SURGERY, THE ANCHOR OF THE BIORAPTOR FRACTURED DURING THE PROCESS OF IMPLANTATION, IT WAS NOT COMPLETELY IMPLANTED IN THE BODY. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THE BACK UP DEVICE WAS USED IN A NEW BONE HOLE. PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. THE PATIENT CURRENT STATUS IS OKAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13109117 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THAT THE BIORAPTOR WAS FRACTURED. PROCEDURE SHOULDER DISLOCATION AND IT WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353159 ↗
• InjuryAug 18, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A REPAIR OF THE GLENOID LIP IN A SHOULDER PROCEDURE, THE BIORAPTOR ANCHOR CRACKED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF A DELAY OCCURRED IN THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339355 ↗
• InjuryJun 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER DISLOCATION TREATMENT, THE BIORAPTOR BROKE. THE DEVICE DID BREAK INSIDE THE PATIENT AND ALL PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986304 ↗
• InjuryJan 15, 2021Break

  IT WAS REPORTED THAT, DURING A SHOULDER ROTATOR CUFF REPAIR, THE BIORAPTOR ANCHOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181206 ↗
• MalfunctionSep 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER JOINT SURGERY, THE ANCHOR BROKE DURING IMPLANTING, ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS, THEN USED A BIORAPTOR AS A BACKUP TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8952966 ↗
• MalfunctionOct 24, 2017Break

  IT WAS REPORTED THAT DURING A SHOULDER JOINT SURGERY THE BIORAPTOR BROKE WHILE IT WAS IMPLANTING. THE ANCHOR WAS REMOVED FROM THE PATIENT AND THE SAME HOLE WAS USED TO IMPLANT A BACKUP BIORAPTOR. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6972751 ↗