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

Catalog Number 05.001.204

Device Problems Failure to Charge (1085); Corroded (1131); Crack (1135)

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

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for service, however did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the device would not charge the battery devices, there was corrosion on the contacts and the feet on the bottom of the device were cracked.Therefore, the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to wear on components from use over time.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 during service and repair pre-testing, it was discovered that the universal battery charger device would not charge the battery devices, the feet on the bottom were cracked and there were corrosions on the contacts.The 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.

• 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: 5041387
• MDR Text Key: 25239794
• Report Number: 3009450871-2015-13147
• 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: company representative,health
• Reporter Occupation: Service and Testing Personnel
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2015
• 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: 1176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2009
• 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