MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS POWER MODULE F/TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.202

Device Problems Temperature Problem (3022); Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported by (b)(6) that the power module device was heating up.It was further reported that there was a tear in the housing on the device.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays in a surgical procedure.A spare device was not available for use.It was not reported if there were any 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

(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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.It was determined the device housing was damaged from dropping.The assignable root cause was determined to be due to misuse, abuse and/or user error.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 F/TRS
• 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: 4129154
• MDR Text Key: 4937641
• Report Number: 3009450871-2014-10418
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1