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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF BATTERY REAMER/DRILL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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SYNTHES OBERDORF BATTERY REAMER/DRILL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 530.605
Device Problems Device Inoperable (1663); Defective Component (2292); Device Operates Differently Than Expected (2913); Naturally Worn (2988)
Patient Problem No Patient Involvement (2645)
Event Date 10/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported by (b)(6) that the battery reamer/drill device had an undetermined malfunction.During service and evaluation, it was observed that the battery reamer/drill device control unit was not functioning and was defective.It was noted that the bearings, seals, and planet carriers were worn.It was also noted that the device failed pre-repair diagnostic tests for function of the off/on/rev mode.It was not reported if this event occurred during a surgical procedure.It was reported that there was no delay in a procedure due to the event.It was not reported if a spare device was available for use.There was no patient involvement.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 report will be submitted accordingly.
 
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Brand Name
BATTERY REAMER/DRILL
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ  CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ   CH4436
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6144589
MDR Text Key61858046
Report Number8030965-2016-15805
Device Sequence Number1
Product Code GEY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530.605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2003
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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