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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.001
Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Facility name, complete address and phone number of reporter were not provided. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. The device was evaluated and the reported condition was confirmed. The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported from the (b)(6) that during an unspecified surgical procedure it was observed that the small battery drive device was functionless and did not move. It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use. There was patient involvement reported. 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.
 
Manufacturer Narrative
It was documented in the initial report that the event occurred during surgery. However, upon subsequent follow-up with the affiliate, it was clarified that the event occurred after surgery. Therefore, the reported condition of the device as functionless and not moving does not meet the criteria of a reportable malfunction as it was not reported to have occurred during a surgical procedure and is unlikely to cause or contribute to serious injury. Therefore, the initial medwatch report was submitted in error and is being retracted. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameSMALL BATTERY 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 Key7382783
MDR Text Key104044775
Report Number8030965-2018-52543
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 11/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.001
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

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