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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES OBERDORF SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.103
Device Problems Device Operates Differently Than Expected (2913); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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

This is report 9 of 11 for the same event: it was reported that during an unspecified surgical procedure, it was observed that two small battery drive devices would not work when used together with nine battery devices. According to the report, the battery devices appeared to short out when used with the small battery drive devices. It was further reported that the battery devices were dead when tested after the surgery, although the universal charger device showed that they were fully charged. There were no delays to the surgical procedure as spare devices were available to complete the surgery successfully. There was patient involvement reported. 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

The actual device was returned for evaluation. Reliability engineering evaluated the device. The external features of the device were visually inspected and it was determined that there was no evidence of abuse or manufacture issues. The device was tested and it was confirmed that the device was damaged. It was determined that the device had a blown fuse. Therefore, the reported condition was confirmed. It was determined that the root cause of the battery failure was due to excessive current that caused the battery to blow the fuse, suggesting that the battery had been connected to a device that had a short circuit. If additional information should become available, a supplemental medwatch report will be submitted accordingly.

 
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Brand NameSMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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 Key5885681
MDR Text Key53445327
Report Number8030965-2016-14537
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 08/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number532.103
Device LOT Number150821
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/08/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/06/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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