MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS UNIVERSAL BATTERY CHARGER II; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.204

Device Problems Circuit Failure (1089); Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that the universal battery charger ii device had blown fuses and a burning smell.According to the reporter, two fuses were blown and the burning smell was coming from the base of the charger near the power cord.It was further reported that the device had no power.It was not reported if the device was used in surgery.There was no patient involvement.It was reported there were no delays in a surgical procedure and a spare device was available for use.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 and the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device was missing the fuses and holder, the power connection was broken, and the contacts in charging bays were corroded.It was determined that these were due improper handling/care and tampering of the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNIVERSAL BATTERY CHARGER II
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5225770
• MDR Text Key: 31570195
• Report Number: 3009450871-2015-14208
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.204
• Device Lot Number: 9079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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