MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FMSTK,M; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Model Number	M-8NS-G1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
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.Additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the cutter device was damaged.Therefore, the reported condition was confirmed.A device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.Concomitant med products and therapy date: attachment device, motor device; 3/3/2020.Udi (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the cutter device was worn and stuck in the attachment device.It was noted that a small amount of debris was identified at the coupling part.It was noted that there were some marks found due to the worn attachment device.The cutter device showed signs of regular usage.It was noted in the service order that the attachment device was stuck to a motor device with an unknown burr device stuck in it that could not be released.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 3MM FMSTK,M
• Common Device Name: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10033757
• Report Number: 1045834-2020-00762
• Device Sequence Number: 14131854
• Product Code: HBE
• UDI-Device Identifier: 00845384012535
• UDI-Public: 00845384012535
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: M-8NS-G1
• Device Catalogue Number: M-8NS-G1
• Device Lot Number: N143136680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1