MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 6MM CRS DBALL,M; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	M-6DC-G1
Medical Device Problem Codes	Material Fragmentation (1261); Separation Problem (4043)
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.Additional narrative: device history review: a review of the device history record 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.Concomitant med products and therapy dates: attachment device, unknown date.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition that the ball cutter device could no longer be unclamped was not confirmed.Therefore, an assignable root cause for the reported condition was not determined.However, during evaluation, it was confirmed that the cutter device was fractured.The assignable root cause resulting from failures identified during evaluation was determined to be due to component failure from 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 failed visual inspection as the cutter ball head was missing.It was noted that the cutter device was received stuck inside a dedicated attachment device and was removed for a separate assessment.During dismantlement of the attachment device, it was determined that there was an unauthorized manipulation of the locking mechanism.It was observed that the cutter ball head was missing, however the device identifier could still be read.It was noted that it was likely that the ball head was removed for better access to interior mechanics of the attachment device.It was noted in the service order that the ball cutter could no longer be unclamped.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 available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 6MM 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
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL ; 6107428552
• MDR Report Key: 12889476
• Report Number: 1045834-2021-01825
• Device Sequence Number: 1362246
• Product Code: HBE
• UDI-Device Identifier: 00845384014195
• UDI-Public: 00845384014195
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 04/14/2025
• Device Model Number: M-6DC-G1
• Device Catalogue Number: M-6DC-G1
• Device Lot Number: P183142794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown