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

Model Number	S-8NS-G1
Medical Device Problem Codes	Dull, Blunt (2407); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: motor device, attachment device, (b)(6) 2021.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.During repair, an evaluation was performed, and it was determined that the initial reported condition of the cutter device not able to be removed from the attachment and motor device was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of the device being dull identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal 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 failed visual inspection.It was further observed that the cutter showed signs of corrosion.It was determined that the cutting tool could be released from attachment and handpiece.It was determined that the device showed signs of used blades but heavy corrosion on its shaft, which was caused by reprocessing the parts while assembled.It was noted in the service order that the attachment device and cutter device were stuck in the motor device and 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,S
• 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: 12182289
• Report Number: 1045834-2021-01246
• Device Sequence Number: 11602232
• Product Code: HBE
• UDI-Device Identifier: 00845384012542
• UDI-Public: 00845384012542
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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 Model Number: S-8NS-G1
• Device Catalogue Number: S-8NS-G1
• Device Lot Number: N463140486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1