MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.202

Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

It was reported from (b)(6) that the power module device heated up ¿strangely following a strange charge¿.The event was not reported to have occurred during surgery.According to the reporter, when the user attempted to charge the device on the universal battery charger device, a circular yellow light appeared on the charger.The reporter stated that the device was left on the charger and the yellow light turned off and a green light appeared.The reporter further stated that during the next usage of the device, it was observed that the device became very.There were no delays to the planned surgical procedure as a spare device was 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).The actual device was returned for evaluation.Reliability engineering evaluated the device and the report could not be confirmed.A functional assessment was performed and the device passed all manufacture's specifications.Therefore, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POWER MODULE FOR TRAUMA RECON SYSTEM
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4803861
• MDR Text Key: 5833290
• Report Number: 3009450871-2015-11375
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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: 05.001.202
• Device Lot Number: 13415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNIVERSAL BATTERY CHARGER DEVICE