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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ELECTRIC PEN DRIVE 60,000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC ELECTRIC PEN DRIVE 60,000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.010
Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/22/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(6). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the electric pen drive device stopped working. It was not reported if there was a delay in the scheduled procedure due to the event. It was reported that an unspecified 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
Device was used for treatment, not diagnosis. The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. The device was evaluated and it was determined that the control unit of the electric pen drive device was not functioning and was defective. It was noted that the reverse function had no function, the left-hand rotation was without function, and the control was defective. It was further determined that the device failed pretest for check function and direction of rotation. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to premature wear. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand NameELECTRIC PEN DRIVE 60,000 RPM
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 Key7430385
MDR Text Key105538136
Report Number8030965-2018-53099
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
PMA/PMN Number
K043310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.010
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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