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

Catalog Number	511.300
Medical Device Problem Codes	Device Inoperable (1663); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: multi-humeral nail device, adaptor device, quick coupling device and handpiece device.(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 1 of 4 for the same event.It was reported from (b)(6) that during an open reduction internal fixation (orif) surgical procedure for a humerus diaphysis fracture using the multi-humeral nail long (mhn long) device, it was observed that the small battery drive device stopped working while drilling the first distal hole.According to the report, the event occurred after a proximal hole was fixed.It was reported that the small battery drive device was in use with a radiolucent drive device, adaptor device and a quick coupling device.It was further reported that the small battery drive device kept running idle with a scratching sound.It was reported that the surgeon reassembled the unit again and tried drilling but could not complete the drilling as the same issue occurred.As a result, the surgeon created the prepared hole with a gimlet and then drilled by hand.It was reported that the same event occurred at the second hole but the surgeon completed drilling using the same manual way.It was reported that the surgeon took time to change the battery and tried the same way at the third hole.It was reported that although the small battery drive device was about to stop, the surgeon managed to complete the drilling.It was reported that there was a 30 minute delay in the surgical procedure and the surgery was completed successfully using the same device.There was patient involvement.There were no 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.Reliability engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 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: 7404030
• Report Number: 8030965-2018-52831
• Device Sequence Number: 785302
• Product Code: HWE
• UDI-Device Identifier: 10886982237385
• UDI-Public: (01)10886982237385(11)160106(21)
• Combination Product (Y/N): N
• 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): 03/14/2018

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: 511.300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1