MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FMSTK,S; DRILLS, BURRS, TREPHINES AND 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	03/26/2021
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.The actual device was returned for evaluation.The cutter device was evaluated and the reported condition that the cutter became stuck in the attachment device and could not be released was not confirmed.It was determined that a user error caused the cutter to remain locked inside the handpiece while the attachment was loose.The cutter could be easily removed by turning the locking mechanism directly.However, during evaluation it was observed that the cutter device showed normal signs of wear on the cutting edges.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.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 showed normal signs of wear on the cutting edges, and the shaft showed signs of reprocessing (foreign substance) inside the assembly.It was noted in the service order that the attachment device was stuck on the handpiece device with a cutter device stuck/jammed inside 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 AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11960094
• Report Number: 1045834-2021-00988
• Device Sequence Number: 1321348
• 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): 04/26/2021

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: N393139658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1