MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.5MM RADIOLUCENT DRILL BIT; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	4200355035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported, that during a t2h procedure.The drill tip broke off.It was also reported, that there were no adverse consequences, no medical intervention and no delays as a result of this event.It was further reported, that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a t2h procedure, the drill tip broke off.It was also reported that there were no adverse consequences, no medical intervention and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
This event was originally reported as part of the voluntary malfunction summary report (vmsr) program under mfr report # 3015967359-2023-00802, submitted on 24 april 2023.This record, mfr report # 3015967359-2023-01149, was filed in error.
Event or Problem Description
It was reported that during a t2h procedure, the drill tip broke off.It was also reported that there were no adverse consequences, no medical intervention and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 3.5MM RADIOLUCENT DRILL BIT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 16962735
• Report Number: 3015967359-2023-01149
• Device Sequence Number: 5225385
• Product Code: HWE
• UDI-Device Identifier: 04546540217165
• UDI-Public: 04546540217165
• 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,Followup
• Report Date (Section B): 10/05/2023

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 Model Number: 4200355035
• Device Catalogue Number: 4200355035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/10/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/17/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 70 KG