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

Catalog Number 05.001.204

Device Problems Break (1069); Crack (1135); Loss of Power (1475); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

It was reported that during service and repair pre-testing, it was observed that the feet on the bottom of the universal battery charger device were cracked.It was further reported that the vent fan was cracked and broken away.The reporter stated that when the device was turn on, the device made a pop sound and lost all power.This event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.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 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.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• 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: 4905858
• MDR Text Key: 15960711
• Report Number: 3009450871-2015-12431
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 06/12/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.204
• Device Lot Number: 1356
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1