MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KEYLESS DRIVER; DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW

Model Number	DRIVER
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation pre-test it was determined that the driver device had vibration.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure.

• Brand Name: KEYLESS DRIVER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - MICRO SAW
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11922974
• Report Number: 1045834-2021-00945
• Device Sequence Number: 10974179
• Product Code: HBE
• UDI-Device Identifier: 00845384001928
• UDI-Public: 00845384001928
• Combination Product (Y/N): N
• PMA/510(K) Number: K965080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: No Information
• Device Model Number: DRIVER
• Device Catalogue Number: DRIVER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/08/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES-76059
• Patient Sequence Number: 1