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

Catalog Number 05.001.204

Device Problems Bent (1059); Circuit Failure (1089); Crack (1135); Loose or Intermittent Connection (1371); Unintended Collision (1429)

Patient Problem No Patient Involvement (2645)

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 device had a dropped pin, loose locking ring which caused a short circuit in the power supply, and the locking ring was overextended.It was further noted that the device failed pre-repair diagnostic tests for "single contact, power-on test".It was noted in the service order a sparkle came off from the charger when taking out a charging battery.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

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which determined 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 is improper assembly.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 request for 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: 5551900
• MDR Text Key: 42619689
• Report Number: 8030965-2016-12260
• 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
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• 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: 03/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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