MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNIVERSAL BATTERY CHARGER II; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	05.001.204
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to user which is user error.Udi (b)(4).
Event or Problem Description
It was reported that during service and evaluation, it was observed that during the charging function test the unit sparked and turned off with a burn smell emitting from the rear of the charger.It was further determined that the device power supply was damaged and the device would not run, there was a blown fuse, and the device was deformed/bent, there was component damage and the device did not function.It was further determined that the device failed pretest for check software revision, general condition, power-on test, and charging function with power module/batteries.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: UNIVERSAL BATTERY CHARGER II
• Common Device Name: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10514848
• Report Number: 8030965-2020-06554
• Device Sequence Number: 3539343
• Product Code: MOQ
• UDI-Device Identifier: 07611819977846
• UDI-Public: 7611819977846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1