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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY-CAS F/532.001+532.010 STD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES POWER TOOLS BATTERY-CAS F/532.001+532.010 STD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.002
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 05/26/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).The reporter's full name was not provided.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was determined that the lid was broken and was seized.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 report will be submitted accordingly.
 
Event Description
This is report 2 of 2 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the small battery drive device malfunctioned and sometimes stopped working when used together with the battery casing device.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any injuries, 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.
 
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Brand Name
BATTERY-CAS F/532.001+532.010 STD
Type of Device
INSTRUMENT, 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6665974
MDR Text Key78386619
Report Number8030965-2017-13191
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 Other
Type of Report Initial
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number532.002
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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