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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY FOR BATTERY POWER LINE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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DEPUY SYNTHES POWER TOOLS BATTERY FOR BATTERY POWER LINE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 530.630
Device Problems Failure to Power Up (1476); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2016
Event Type  malfunction  
Manufacturer Narrative
(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
This is event 2 of 2 of the same event.It was reported that during an unspecified surgical procedure, it was discovered that the battery oscillator device damaged multiple batteries devices because it would not turn.It was unknown how many batteries were damaged.According to the reporter some surgeries were rescheduled because no battery devices were available.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.
 
Manufacturer Narrative
Additional narrative: during subsequent follow-up, additional information was received.It was reported that a large number of batteries were used and failed due to the failure experienced from the large bone orthopedic battery oscillator device.It was further reported that seven patients were inconvenienced by this device failure in that their procedures were either delayed or rescheduled to a later date.It was reported that there were no serious injuries or death.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
BATTERY FOR BATTERY POWER LINE II
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
n/i
n/i
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
n/i
n/i
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6147209
MDR Text Key62187939
Report Number8030965-2016-15825
Device Sequence Number1
Product Code GEY
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 Other
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530.630
Device Lot NumberN/I
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/23/2016
Initial Date FDA Received12/06/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
BATTERY OSCILLATOR DEVICE
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