MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.0MM SWANSON PILOT POINT BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	1608002131
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery on proximal finger, the tip of the drill bit broke.It was also reported that the surgeon made multiple attempts to retrieve the broken tip but was unsuccessful.It was further reported the procedure was completed successfully without a clinically significant delay.
Additional Manufacturer Narrative
The quality investigation is complete.

• Brand Name: 2.0MM SWANSON PILOT POINT BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 16278008
• Report Number: 3015967359-2023-00348
• Device Sequence Number: 6871197
• Product Code: GFF
• UDI-Device Identifier: 04546540030528
• UDI-Public: 04546540030528
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1608002131
• Device Catalogue Number: 1608002131
• Device Lot Number: 22101017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown