MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8 INCH PEG DRILL; BIT, DRILL

Catalog Number	6541-4-518
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During drilling of triathlon ap sizer, the drill broke off and strayed into the bone, which was radiographed and removed.In addition, bone grafting was performed because of removal bone to locate the broken drill.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon drill bit was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated the device has fractured mid way up the shaft where the flutes initiate.Damage in the fluted region suggesting contact with another material indicative of mechanical damage.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been other similar events for the lot referenced.Conclusions: it was reported that the the drill broke off and strayed into the bone, which required a radiograph and bone graft to be removed.Visual inspection of the returned device indicated the device has fractured mid way up the shaft where the flutes initiate.Damage in the fluted region suggesting contact with another material indicative of mechanical damage.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During drilling of triathlon ap sizer, the drill broke off and strayed into the bone, which was radiographed and removed.In addition, bone grafting was performed because of removal bone to locate the broken drill.
Additional Manufacturer Narrative
Corrected data: d4 expiration date in follow-up 1 entered in error.Reusable device.No expiration date.An event regarding crack/fracture involving a triathlon drill bit was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated the device has fractured mid way up the shaft where the flutes initiate.Damage in the fluted region suggesting contact with another material indicative of mechanical damage.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been other similar events for the lot referenced.Conclusions: it was reported that the drill broke off and strayed into the bone, which required a radiograph and bone graft to be removed.Visual inspection of the returned device indicated the device has fractured mid way up the shaft where the flutes initiate.Damage in the fluted region suggesting contact with another material indicative of mechanical damage.It is likely that the reported device had been damaged through use over time as mechanical damage was observed and the failure occurred 14 years after the device was manufactured.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During drilling of triathlon ap sizer, the drill broke off and strayed into the bone, which was radiographed and removed.In addition, bone grafting was performed because of removal bone to locate the broken drill.

• Brand Name: 1/8 INCH PEG DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18873006
• Report Number: 0002249697-2024-00363
• Device Sequence Number: 3008401
• Product Code: HTW
• UDI-Device Identifier: 07613327241440
• UDI-Public: 07613327241440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2010
• Device Catalogue Number: 6541-4-518
• Device Lot Number: SC5A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 07/19/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 07/09/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian