MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ADAPTOR FOR RADIOLUCENT DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	532.031
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Concomitant medical devices and therapy dates: radiolucent drive device, drill bit device, battery device; (b)(6) 2020.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
This is report 2 of 2 for the same event.It was reported from (b)(6) that during an osteosynthesis surgery for a humeral shaft fracture surgical procedure, it was observed that the radiolucent drive device, while being used with an adaptor device, stopped during insertion of the distal locking screws, which made the device unusable.It was reported that there was no problem when the user drilled near the cortical bone, however the device sound stopped gradually and then finally stopped with a ticking sound.It was noted that the user switched to a freehand drill device and inserted the first locking screw without the radiolucent drive device.It was further reported that prior to the insertion of the second locking screw, the user replaced the battery device and the drill bit device which had heated and the adapter and connecting part of the device were cooled with saline.However, during the insertion of the second screw, the radiolucent drive stopped again and the user inserted the screw with the freehand drill point.It was reported that there was a thirty minute delay in the surgical procedure.It was noted that the patient had good bone quality.It was not reported if there was a spare device was available for use.There was 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.
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.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device passed all manufactures specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ADAPTOR FOR RADIOLUCENT DRIVE
• 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: 9728100
• Report Number: 8030965-2020-01134
• Device Sequence Number: 19447984
• Product Code: HWE
• UDI-Device Identifier: 07611819107205
• UDI-Public: 07611819107205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/04/2020

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 Catalogue Number: 532.031
• Device Lot Number: MA1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1