NA 03.111.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10886982072283), received between Mar 9, 2017 and Jun 15, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Break” (40 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT THE TIP OR THE HOLDER OF THE MILLING CUTTERS HAS BROKEN OFF AND CAN NO LONGER BE USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505494 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382617 ↗
• MalfunctionMar 28, 2025Break; Break

  THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. ONE OF THE PRONGS HAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720232 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE BONE GRAFT HARVESTING INSTRUMENTS ON THE FOOT INSTRUMENTS LOAN SET. THE SET WAS MISSING 1/1 GUIDE WIRE WITH STOP 3.2/1.6 SO AN ALTERNATIVE WIRE WAS USED TO GUIDE THE TREPHINE. DURING THE PROCEDURE, THE 3 TABS ON THE SHAFT FOR TREPHINE BROKE OFF THE INSTRUMENT. ALL WERE RETRIEVED FROM THE PATIENT AND THERE WAS NO ADVERSE EVENT OR DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704895 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE CONSULTANT WAS USING THE TREPHINE ATTACHMENT WHEN THE END OF IT BROKE OFF. THIS OCCURRED OUTSIDE THE PATIENT. DURING SAME OPERATION, THE CONSULTANT WAS UNABLE TO THREAD THE HOLDING SLEEVE INTO THE COMPRESSION DEVICE. ON CLOSER INSPECTION, THE THREADS WERE DAMAGED ON THE INSTRUMENT. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR A SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19522264 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT ON JANUARY 23, 2024, IT WAS NOTICED THAT PART NUMBER 03.111.030 WITH LOT NUMBER 2550855 HAD A PIECE BROKEN OFF. SET WAS AT OFFICE NOT INVOLVED IN CASE. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) SHAFT F/TREPHINE+EXTRACTION ATTACHMENT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645223 ↗
• MalfunctionDec 14, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 22, 2023, DURING LOAN KIT INSPECTION, THE LOAN KIT TECHNICIAN FOUND THAT THE ATTACHMENT TIP HAD BROKEN. THIS REPORT INVOLVES (B)(4) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329024 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 13, 2023, THERE WAS A DAMAGED SHAFT WHICH HAS ATTACHMENTS FROM THE BONE HARVESTING SET. THE TIP OF THE SHAFT WAS BROKEN, AND THE ATTACHMENTS COULD NO LONGER BE ATTACHED TO THE BONE HARVESTING SET. THERE WAS NO PATIENT CONSEQUENCE; THIS HAPPENED POSTOPERATIVELY. THIS REPORT INVOLVES ONE SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266770 ↗
• MalfunctionOct 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, IT WAS IDENTIFIED THAT THE TIP OF THE INSTRUMENT HAS SNAPPED OFF. THIS WAS IDENTIFIED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867838 ↗
• MalfunctionJul 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE REAMER FOR BONE GRAFT SYSTEM NEEDED TO BE REPLACED AS SOON AS POSSIBLE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS REVEALED THAT SHAFT F/TREPHINE+EXTRACTION ATTACHMENT WAS OBSERVED WITH ONE OF THE PRONGS BROKEN OFF. THIS DEVICE CONDITION WAS RE-EVALUATED AND DETERMINED REPORTABLE. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400370 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A BROKEN BONE HARVESTER KIT TOOL. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832741 ↗
• MalfunctionFeb 7, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 TREPHINE WAS FOUND BROKEN IN SET. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313671 ↗
• MalfunctionMay 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING STERILE PROCESSING ON (B)(6) 2022, IT WAS OBSERVED THAT BOTH END PIECES ON THE BONE HARVESTER TREPHINE DEVICE WERE BROKEN OFF. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SHAFT F/TREPHINE+EXTRACTION ATTACHMENT DEVICE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269585 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SHAFT FOR TREPHINE WAS GIVEN TO SALES REP BY SPD WITH A BROKEN TREPHINE PIECE. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13622036 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR UNKNOWN REASON. DURING USE OF THE BONE HARVESTING SHAFT, THE TIP BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052010 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, WHEN PLACING THE BONE HARVESTING DEVICE ON THE ATTACHMENT, A SMALL PIECE OF THE ATTACHMENT BROKE OFF. THERE WERE FRAGMENTS GENERATED AND IT IS UNKNOWN IF THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043075 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, THE SURGEON WAS USING THE BONE HARVESTING INSTRUMENT SET TO COLLECT ILIAC BONE GRAFT. HE USED A MALLET TO HIT THE END OF THE HANDLE IN ORDER TO GET THE TREPHINE TO SINK INTO THE BONE. WHEN SURGEON TRIED TO PULL THE HANDLE, THE TREPHINE STAYED IN THE BONE AND THE DISTAL END OF THE SHAFT FOR THE TREPHINES BROKE OFF. THE PIN ON THE QUICK CONNECT RELEASE PORTION OF THE HANDLE BROKE OFF AS WELL. THE DISTAL END OF THE SHAFT FOR THE TREPHINES BROKE OFF. THERE WAS NO SURGICAL DELAY NOTED. FRAGMENTS GENERATED WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - MALLET (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422640 ↗
• MalfunctionJul 20, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE TIP OF THE INSTRUMENT BROKE OFF DURING SURGERY. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER INSTRUMENT. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199188 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE SHAFT FOR TREPHINE ATTACHMENTS WAS BEING USED TO COLLECT AUTOGRAFT FROM THE PATIENT'S CALCANEUS. WHILE TRYING TO PULL THE GRAFT OUT, THE END OF SHAFT FOR TREPHINE ATTACHMENTS SHEARED OFF. FRAGMENTS WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11650576 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEM WAS GIVEN BY STERILE PROCESSING DEPARTMENT STAFF WITH THE TABS BROKEN OFF TREPHINE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624338 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT DURING ORTHOPEDIC PROCEDURE FOR BONE GRAFT HARVESTING OF DISTAL FEMUR ON (B)(6) 2021, THE SHAFT OF THE BONE HARVESTING INSTRUMENT BROKE; RETAINING TIP/PRONGS BROKE OFF. ALL FRAGMENTS WERE RECOVERED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259993 ↗
• MalfunctionJan 5, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE GETTING MORE BONE GRAFT, FOUND THAT THE SHAFT END HAD BROKEN, AND THE TIPS HAD COME OFF. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120075 ↗
• MalfunctionDec 23, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE TIP OF THE INSTRUMENT BROKE OFF INTO TWO (2) PIECES INTRAOPERATIVELY. NO PARTS REMAINED IN PATIENT AND THERE WAS NO ADVERSE PATIENT HARM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER INSTRUMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065522 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHAFT FOR TREPHINE ATTACHMENTS HAD ALL THREE (3) PRONGS BROKEN OFF. IT WAS FOUND AFTER STERILIZATION PROCESSING DEPARTMENT (SPD) HAD CLEANED IT. IT HAS BEEN REMOVED FROM THE SET. THERE IS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924732 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE BONE HARVESTING INSTRUMENTATION WAS NOT PERFORMING PROPERLY. THE SURGEON NOTICED THAT THE CONNECTING SHAFT WOULD NOT HOLD THE REAMER HEADS WELL ENOUGH TO EXTRACT BONE GRAFT WITHOUT DISCONNECTING THE REAMER HEAD FROM THE SHAFT ITSELF. AFTER A FEW TRIES, ONE OF THE TWO PRONGS THAT CONNECT THE TREPHINE TO THE SHAFT BROKE OFF, RENDERING THE BONE HARVESTING INSTRUMENTATION UN-USABLE. HOWEVER, ENOUGH BONE GRAFT WAS OBTAINED TO COMPLETE THE CASE BEFORE THIS HAPPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SHAFT FOR TREPHINE ATTACHMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824148 ↗