MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO Ø2.5MM X 135MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	542020
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "patient presented to operating room (or) for revision of tibial hardware.During the procedure a drill bit broke while inside of the patient's bone.All pieces of the bit were removed from the patient and accounted for, collected in a cup, and removed from the surgical field.The pieces were then given to management.Per the intraoperative x-ray films, no fragments were left inside the patient.".
Event or Problem Description
As reported: "patient presented to operating room (or) for revision of tibial hardware.During the procedure a drill bit broke while inside of the patient's bone.All pieces of the bit were removed from the patient and accounted for, collected in a cup, and removed from the surgical field.The pieces were then given to management.Per the intraoperative x-ray films, no fragments were left inside the patient.".
Additional Manufacturer Narrative
Correction - please refer to g1 reporting contact, h6 health impact code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Although the reported event could not be confirmed, incidents observed with pangea drills were acknowledged by r&d.Tests will be performed to determine the root cause(s) and solutions will be taken accordingly to increase the reliability of the instruments and user's satisfaction.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.No indications of material, manufacturing or design related problems were found during the investigation.

• Brand Name: DRILL BIT, AO Ø2.5MM X 135MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21708512
• Report Number: 0008031020-2025-00445
• Device Sequence Number: 21350159
• Product Code: HWE
• UDI-Device Identifier: 07613327614244
• UDI-Public: (01)07613327614244(10)37523614
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 542020
• Device Lot Number: 37523614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White