MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BATTERY F/BATTERY POWER LINE II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.630

Device Problems Failure to Charge (1085); Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

This is report 5 of 11 for the same event.It was reported from united kingdom that during charging process, it was observed that six battery devices stopped working and were not charging in universal battery charger devices.According to the report, the red light warning appeared on the universal battery charger devices.It was further reported that the user attempted to charge six battery devices with five universal battery charger devices.The reporter did not specify which devices were malfunctioning.This event was not related to surgery.There were no delays to a planned surgical procedure.It was not reported if spare devices were available for use.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the fuse in the battery tripped due to a short circuit.Therefore, the reported condition was confirmed.It was determined that the malfunction was caused by a damaged control unit in the handpiece device which had caused damage on the fuse in the battery device.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BATTERY F/BATTERY POWER LINE II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 4754662
• MDR Text Key: 5783502
• Report Number: 3009450871-2015-11307
• Device Sequence Number: 1
• Product Code: GEY
• 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: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.630
• Device Lot Number: 130821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BATTERY CHARGER DEVICE; BATTERY CHARGER DEVICE; BATTERY CHARGER DEVICE; BATTERY DEVICE; BATTERY DEVICE; BATTERY DEVICE; BATTERY CHARGER DEVICE; BATTERY DEVICE; BATTERY CHARGER DEVICE