MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 4MM DIAMOND BALL, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	MA15-4D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
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, bearing sleeve device, (b)(6) 2020.Device history record review: a device history review was performed and no non-conformances were identified related to the reported condition complaint history review: a complaint history review was performed which indicated that there were no complaints found for the reported lot number.Device evaluation: the actual device was returned for evaluation.During repair, quality engineering performed an evaluation, and it was determined that the reported condition was confirmed.The assignable root causes were determined to be traced to user, which is user error and environmental conditions.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 was jammed inside the bearing sleeve and attachment device.During the assessment it was noted that it was possible to remove the cutter and bearing sleeve from the attachment locking mechanism.It was further determined that the cutter shaft was bent close to the diamond ball and at its locking groove.It was not possible to connect the device to the service center's equipment due to the dent at the end of the shaft.It was further observed that the diamond ball carried residues, and along the cutter shaft, there were signs of usage and corrosion detected, which most likely resulted from reprocessing of all the three parts interlocked.It was determined that the cutter could not be inserted and was damaged.It was noted in the service order that the device had an undetermined malfunction while being used together with the attachment and bearing sleeve device.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.However, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 4MM DIAMOND BALL, 15CM
• 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: 11426518
• Report Number: 1045834-2021-00344
• Device Sequence Number: 19644142
• Product Code: HBE
• UDI-Device Identifier: 00845384004578
• UDI-Public: 00845384004578
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K042783
• 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): 12/22/2020

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: MA15-4D
• Device Catalogue Number: MA15-4D
• Device Lot Number: P063141648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1