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

Catalog Number 05.001.204

Device Problems Bent (1059); Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.

Event Description

It was reported by (b)(6) that during service and evaluation, it was observed that the universal battery charger device contacts were bent and cracked.It was noted that the contact pin dropped from the power module charging bay and the lock ring overstrained.It was further noted that the device failed pre-repair diagnostic tests for general condition and single contact.It was noted in the service order ¿during picking up the battery charger smoke came out of the battery charger and blue light does not work¿.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 this event was unknown.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 confirmed.The assignable root cause was determined to be due to a false production, which is manufacturing / process error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device evaluation: further investigation determined that the contact pin fell out of the charging bay because the snap ring inside the charger, which holds the pin was overextended.As a result, the snap ring fall inside of the power supply and caused a short circuit.It was determined that the most probable root cause was improper assembly of the snap ring in the charging bay.It was also determined that the malfunction could be related to the lack of performance of the snap ring material.It was determined that the assignable root cause was a manufacturing / process error - production false, defective.A corrective action has been requested from the supplier to address this issue.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: UNIV-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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5567246
• MDR Text Key: 42969102
• Report Number: 8030965-2016-12336
• 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,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2010
• 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