MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC TRINKLE REDUCTION DRIVE UNIT; DRIVER, SURGICAL, PIN

Catalog Number	532.019
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during service and repair pre-testing, it was observed that the ball inside the coupling piece on the reduction drive device came out.It was further determined that the device failed steps 80 - 100.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 report will be submitted accordingly.
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device ball inside coupling piece came out.Therefore, 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 will be submitted accordingly.

• Brand Name: TRINKLE REDUCTION DRIVE UNIT
• Common Device Name: DRIVER, SURGICAL, PIN
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7639167
• Report Number: 8030965-2018-54646
• Device Sequence Number: 16526292
• Product Code: GFC
• UDI-Device Identifier: 10886982240545
• UDI-Public: (01)10886982240545(11)080313
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 532.019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/06/2018
• Patient Sequence Number: 1