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

Catalog Number	532.103
Medical Device Problem Codes	Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.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 or Problem Description
This is report 4 of 8 for the same event.It was reported from (b)(6) that during an open reduction internal fixation (orif) of the acetabulum, it was observed that eight lithium battery devices were not charging properly.It was reported that when the devices were inserted into the battery charger device the amber light came on initially, and about 30 seconds later the red light came on.It was reported that there was a 10 minute delay in the procedure due to the event.It was not reported if a spare device was available for use.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 will be submitted accordingly.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.The external features of the returned device were visually inspected.No evidence of customer abuse or manufacture issues were observed.The device was tested and it was confirmed that the device did not function and would not take a charge.The device was taken apart and it was discovered that the device had blown fuse which caused the failure.It was determined that the failure was due to an excessive current that would cause the device to blow a fuse, suggesting that the battery had been connected to a device that had a short circuit.The assignable root cause was determined to be due to device use.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE 14.4 VOLT LITHIUM IO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7045898
• Report Number: 8030965-2017-50035
• Device Sequence Number: 13697468
• Product Code: HWE
• UDI-Device Identifier: 07611819408333
• UDI-Public: (01)07611819408333(11)150724(10)150623
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 532.103
• Device Lot Number: 150623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1