MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 5MM CRS DBALL,M; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	M-5DC-G1
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: attachment device.Device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device, and it was determined that the reported condition was confirmed.It was further determined that the root cause associated with the dull cutter was due to normal wear, and the root cause of the corroded shaft was due to reprocessing of the cutter inside the attachment (traced to environment).The assignable root cause of the dull cutter was determined to be due to component failure from wear.Udi: (b)(4).
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the cutter device would not cut/dull.The cutter was removed from the attachment device and it was determined that the cutting head showed signs of wear.It was further observed that the shaft had corrosion/rusting/pitting and the device failed visual inspection.It was noted in the service order that the cutter device had an undetermined malfunction, and the attachment device did not work anymore.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 5MM CRS DBALL,M
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12484613
• Report Number: 1045834-2021-01581
• Device Sequence Number: 14637548
• Product Code: HBE
• UDI-Device Identifier: 00845384013037
• UDI-Public: 00845384013037
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: Health Professional
• Device Expiration Date: 01/26/2025
• Device Model Number: M-5DC-G1
• Device Catalogue Number: M-5DC-G1
• Device Lot Number: P073141131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1