MAUDE Adverse Event Report: Stryker GmbH Drill Bit, AO D2.5mm x 215mm; Instrument, surgical, orthopedic, AC-powered motor and accessory/attachment

Catalog Number	542021S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "during a pangea ph procedure, drilling was performed through the posterior screw hole in the second row from the proximal side.After screw insertion, fluoroscopic/x-ray confirmation revealed that the tip of the drill bit had fractured and remained within the bone.The surgeon determined that removal of the fractured drill bit tip was not feasible and therefore completed the procedure with the fragment left in situ.".
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 215mm
• 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: 50500183
• Report Number: 0008031020-2026-01386
• Device Sequence Number: 9459455
• Product Code: HWE
• UDI-Device Identifier: 07613327614596
• UDI-Public: 07613327614596
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 542021S
• Device Lot Number: 41562205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/28/2026
• 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 Age: 77 YR
• Patient Sex: Female