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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
''drill broke off while pre-drilling a pin hole.The procedure was completed using replacement.All broken parts have been completely removed, for data protection reasons, no information of the patient is possible.''.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon drill bit was reported.The event was confirmed via evaluation of the photographs provided.Method and results: product evaluation and results: visual inspection: the device was not returned, however, photograph were provided for review which indicated the device has fractured mid way up the drill bit.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 during surgery.The device was not returned, however, photograph were provided for review which indicated the device has fractured mid way up the drill bit.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
''drill broke off while pre-drilling a pin hole.The procedure was completed using replacement.All broken parts have been completely removed, for data protection reasons, no information of the patient is possible.''.

• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19861440
• Report Number: 0002249697-2024-01048
• Device Sequence Number: 8291092
• Product Code: HTW
• UDI-Device Identifier: 07613327241440
• UDI-Public: 07613327241440
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6541-4-518
• Device Lot Number: 347773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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 Sex: Unknown