NA 213817Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705003280), received between Sep 26, 2019 and Aug 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE, A FISHMOUTH DRILL GUIDE DURABLE DRILL GUIDE DEVICE AND A STABILIZATION DRILL BIT DURABLE DEVICE DESIGNED FOR DRILLING 2.9MM DRILL HOLE DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, THERE WERE METAL SHAVINGS THAT CAME OFF INTO THE JOINT DURING USE. IT WAS REPORTED THAT THE SHAVINGS WERE REMOVED VIA SHAVER/SUCTION. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064713 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE, A FISHMOUTH DRILL GUIDE DEVICE WAS USED. ACCORDING TO THE REPORT, THERE WERE METAL SHAVINGS THAT CAME OFF OF IT INTO THE JOINT. IT WAS REPORTED THAT THE SHAVINGS WERE REMOVED VIA SHAVER/SUCTION. ANOTHER LIKE DEVICE WAS USED TO IMPLANT REMAINING ANCHORS WITH A DELAY OF 15 MINUTES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990431 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY LABRAL REPAIR PROCEDURE, IT WAS OBSERVED THAT THE LUPINE STABILIZATION FISHMOUTH DRGDE CAME OFF OF IT INTO THE JOINT THEN THE SHAVINGS WERE REMOVED VIA SHAVER/SUCTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476984 ↗
• MalfunctionDec 21, 2022Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE OBTURATOR (STABILIZATION) AND FISHMOUTH DRILL GUIDE DEVICES WERE BOTH BENT WHILE IN USE TOGETHER. ACCORDING TO THE REPORT, IT WAS STIFF TO INSERT AND REMOVE THE FISHMOUTH DRILL GUIDE FROM THE OBTURATOR (STABILIZATION). IT WAS FURTHER REPORTED THAT THE OBTURATOR (STABILIZATION) WAS ROUGH ON DISTAL TIP WITH METAL BENT TO DEFORM FISHMOUTH DRILL GUIDE APERTURE; AND THAT THERE WERE SMALL METAL SHAVINGS DISLODGED FROM OBTURATOR (STABILIZATION) DURING DRILLING OF GLENOID. IT WAS REPORTED THAT ALL THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16026526 ↗
• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT TWO OF THE FISHMOUTH DRILL GUIDE AND TWO OF THE DRILL BIT (STABILIZATION) WERE DULL AND CREATED METAL SHAVINGS. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT´S BODY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201774 ↗
• MalfunctionJun 26, 2020Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT TWO OF THE FISHMOUTH DRILL GUIDE AND TWO OF THE DRILL BIT (STABILIZATION) WERE DULL AND CREATED METAL SHAVINGS. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT´S BODY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201768 ↗
• MalfunctionDec 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE TIP OF TWO OF THE LUPINE STABILIZATION FISHMOUTH DRGDE *EA WERE BENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438837 ↗
• MalfunctionSep 26, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S LUPINE FISHMOUTH DRILL GUIDE AND LUPINE DRILL BIT CREATED METAL SHAVINGS IN THE PATIENT'S JOINT SPACE. THE SALES REP STATED THAT THE METAL SHAVINGS WERE REMOVED WITH THE SHAVER AND THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE DEVICES AS THE ISSUE OCCURRED TOWARDS THE END OF THE CASE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE APPROXIMATELY FIVE YEARS OLD AND HAVE SEEN HEAVY USE IN THE FIELD. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126756 ↗