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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the drill bit broke.It was also reported that the fractured tip of the drill bit was still stuck in the bone.It was further reported that the bone was shaved around the drill tip so the fragment could be removed successfully.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the drill bit broke.It was also reported that the fractured tip of the drill bit was still stuck in the bone.It was further reported that the bone was shaved around the drill tip so the fragment could be removed successfully.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.

• 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: 14938705
• Report Number: 3015967359-2022-01260
• Device Sequence Number: 6178230
• Product Code: GFG
• UDI-Device Identifier: 04546540348593
• UDI-Public: 04546540348593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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 Expiration Date: 05/01/2023
• Device Model Number: 4200355042
• Device Catalogue Number: 4200355042
• Device Lot Number: 20143017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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