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

Model Number	L-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	04/27/2021
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: attachment device, drill 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 reported condition was confirmed.It was determined that the most probable cause for the found defect was improper handling and improper reprocessing, and the regular wear on the blades could be assessed as normal wear.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 the visual inspection.It was determined that the cutter was stuck inside the attachment device and it was hard to insert the cutter into an attachment, but still possible to lock the assembly into a handpiece device.It was observed that the cutter showed discoloration, traces of foreign substance and corrosion on its shaft.The diameter was measured, and it was determined that it exceeded the tolerance of 0.01mm (millimeter) where the foreign substance and discoloration was detected.It was determined that the cutter blades showed regular signs of wear.It was noted in the service order that the cutter device was stuck in the attachment device and could not be released.The reporter stated that the cutter information was unable to be determined because it was stuck in the attachment.The devices were used together with the drill device.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,L
• 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: 12094430
• Report Number: 1045834-2021-01142
• Device Sequence Number: 16952838
• Product Code: HBE
• UDI-Device Identifier: 00845384012528
• UDI-Public: 00845384012528
• 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): 05/23/2021

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: L-8NS-G1
• Device Catalogue Number: L-8NS-G1
• Device Lot Number: N493140744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1