MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC MODIFIED TRINKLE DRILLING ATTACH F/BPL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	530.793
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that a component from the trinkle drilling attachment device was damaged.It was further determined that the device fell apart and had an unattached failure.It was noted in the service order that during an unspecified surgical procedure, it was discovered that the device was idle due to the breakage of an internal metal part and the drill did not rotate.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Evaluation update: h6: further investigation was performed on this device by quality engineering.During investigation, it was observed that the device did not function anymore.It was further determined that the transmission shaft of the device was broken and could no longer transmit the power to the coupling piece.It was observed that the transmission shaft also held the device together.It was determined that since the shaft was broken, it the device was broken into two pieces.It was further determined that the device failed pretest for general condition and check for untrue running.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MODIFIED TRINKLE DRILLING ATTACH F/BPL
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8772048
• Report Number: 8030965-2019-66076
• Device Sequence Number: 13963860
• Product Code: HWE
• UDI-Device Identifier: 07611819802643
• UDI-Public: 07611819802643
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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 Catalogue Number: 530.793
• Device Lot Number: 9373506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1