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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 Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter¿s phone number: (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
It was reported from (b)(6) that the small battery drive device sometimes did not work. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown, however it was reported that the event occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The device availability was inadvertently documented as january 26, 2018 in the initial report. The date returned to manufacturer was corrected to march 7, 2018. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the motor of the small battery drive device seized, moved heavily and was jammed. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to wear from normal use and servicing. 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
Manufacturer (Section G)
SYNTHES PRODUKTIONS GMBH
hauptstrasse 24
waldenburg 4437
SZ 4437
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7272785
MDR Text Key100154842
Report Number8030965-2018-51126
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2018
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 Manufacturer03/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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