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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES PRODUCTS LLC ADAPTOR FOR RADIOLUCENT DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.031
Device Problems Device Inoperable (1663); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: multi-humeral nail device, radiolucent drive device, quick coupling device and small battery drive 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 Description
This is report 2 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.
 
Manufacturer Narrative
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.
 
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Brand NameADAPTOR FOR RADIOLUCENT DRIVE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7404023
MDR Text Key104614368
Report Number8030965-2018-52833
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

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