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

Catalog Number 532.103

Device Problems Failure to Charge (1085); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).Initial reporter's phone number: (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 report 1 of 9 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery devices gave an error signal and did not charge anymore when used with a universal battery charger.It was reported that there was a delay in the procedure due to the event.However, the length of the surgical delay was unspecified.It was reported that unspecified spare devices were available for use.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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.

Manufacturer Narrative

During subsequent follow-up with the reporter, it was clarified that there was approximately thirteen to fifteen minutes delay in the surgical procedure.Correction: it was further reported that after surgery, the defective battery devices were tested on all three battery chargers as a confirmation of the battery defectiveness.The mention of the battery chargers displaying the red light on the chargers was in reference to the outcome of testing the battery devices.The reporter stated that there was not alleged malfunction against the battery charger devices.Therefore, the event numbering represented in the initial report has been updated from ¿report 1 of 9 for the same event¿ to ¿report 1 of 6 for the same event¿.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION
• Type of Device: INSTRUMENT, 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5976344
• MDR Text Key: 55936862
• Report Number: 8030965-2016-14924
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.103
• Device Lot Number: 151207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BATTERY DEVICES; UNIVERSAL BATTERY CHARGER DEVICES