MAUDE Adverse Event Report: STRYKER GMBH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2351-4218S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical drill bit tip broke during surgery (right femur).Operating room team was unable to recover the drill bit tip.

• Brand Name: NA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 22001947
• Report Number: 22001947
• Device Sequence Number: 7267339
• Product Code: LXH
• UDI-Device Identifier: 07613327350319
• UDI-Public: (01)07613327350319(17)350228(10)K1156B9
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/06/2025
• Report Date (Section F): 05/06/2025

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 Model Number: 2351-4218S
• Device Catalogue Number: 2351-4218S
• Device Lot Number: K1156B9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/06/2025