MAUDE Adverse Event Report: Stryker GmbH Drill Bit, AO D2.5mm x 135mm; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	542020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a routine left total hip makoplasty the surgeon had finished putting the implants in the patient.He then used a drill bit to pass suture for the initial portion of closure of the hip capsule.Whilst doing this the fluted portion of the drill bit broke off while being used in the patient.An initial search was done for the bit with no results, so x-ray was notified and came to the room.Two shots were taken to assess where the drill bit was located.The surgeon read the x-rays and determined that the broken portion of the drill bit was in the patients left femur.He decided to leave the drill bit in situ as the costs of retrieving it would be greater that the benefits of it being removed.The patients hip was then closed and the surgery was concluded.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: Drill Bit, AO D2.5mm 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50792135
• Report Number: 0008031020-2026-01597
• Device Sequence Number: 10515314
• Product Code: HWE
• UDI-Device Identifier: 07613327614244
• UDI-Public: 07613327614244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Catalogue Number: 542020
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female