MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FMSTK,L AGG,8.9MM EXP,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	S-8NS-M-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	05/07/2021
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, short attachment device (b)(6) 2021.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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was observed that the cutting device was stuck inside an attachment device when it was received from the customer, however it was possible to lock and unlock the devices with a dedicated handpiece during testing.Therefore, the reported condition that the cutter device could not be removed was not confirmed.However, the malfunctions found during service and evaluation have been confirmed.It was determined that the most probable cause for the found defect was normal wear over time and the detected debris could be linked to improper reprocessing.The assignable root cause was determined to be due to component failure from normal wear and environment.Concomitant med products: handpiece device and attachment device.Udi: (b)(4).
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the burr device failed visual inspection due to a small dent, notable signs of regular usage and visible debris.It was noted in the service order that the motor device hand piece had a short attachment device with an unknown cutter device jammed and could not be released from the drill hand piece.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 available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 3MM FMSTK,L AGG,8.9MM EXP,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: 12124389
• Report Number: 1045834-2021-01148
• Device Sequence Number: 14656870
• Product Code: HBE
• UDI-Device Identifier: 00845384013082
• UDI-Public: 00845384013082
• 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): 05/16/2021

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-M-G1
• Device Catalogue Number: S-8NS-M-G1
• Device Lot Number: N073135811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1