MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL

Model Number	4200355042
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an open reduction with internal fixation of non-union intertrochanteric fracture surgery; the tip of the drill bit broke.It was also reported that the broken piece remained in the patient.It was further reported that there was no medical intervention, with no clinically-significant surgical delay as a result of this event, and that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.Device not returned.

• Brand Name: 4.2MM RADIOLUCENT DRILL BIT
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16231753
• Report Number: 3015967359-2023-00082
• Device Sequence Number: 12392509
• Product Code: GFG
• UDI-Device Identifier: 04546540348593
• UDI-Public: 04546540348593
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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 Expiration Date: 08/01/2025
• Device Model Number: 4200355042
• Device Catalogue Number: 4200355042
• Device Lot Number: 22161017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Unknown