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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.110
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 that during an unspecified surgical procedure of the pelvis, it was observed that the small battery drive device had intermittent power. It was noted that the device was more off than on. It was reported that there was no delay in the procedure as an identical spare device was available for use. It was reported that the the surgery was completed successfully. There were no patient or user injuries reported. It was reported there was no medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and the reported condition of intermittent power was confirmed. An assessment was performed on the device which determined the unit was working intermittently. It was also noted that one safety disc was missing, one insulation sleeve started to come out, and the electric motor was damaged (noise). The assignable root cause was determined to be due to normal wear from normal use and servicing over time. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand NameSMALL BATTERY DRIVE II
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
hauptstrasse 24
waldenburg CH443 7
SZ CH4437
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5802982
MDR Text Key50621046
Report Number8030965-2016-14250
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.110
Device Lot Number1445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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