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

Catalog Number 05.001.202

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 02/13/2015

Event Type  malfunction  

Event Description

This is report 3 of 6 for the same event.It was reported from (b)(6) that during the second insertion for distal transverse locking procedure with expert tibial nail (etn), it was observed that the battery handpiece device ceased movement.According to the report, the first insertion was successful.The battery handpiece device was in use with two power module devices, an adaptor device and two lids for the battery handpiece device.As a result, there was a 20 minute delay in the surgical procedure.It was not reported if there was a spare device available for use.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)(4).The manufacturing location was unknown.The serial number was unknown.Therefore, device manufacture date is unknown.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 manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.(b)(4).Device manufacture date: the device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as jan 24, 2011.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all electronic testing.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.However, during evaluation, it was observed that the device had an extraordinary coarse and cracked housing, and discolored liquid indicators.It was determined that the device showed signs of damage caused by dropping.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• 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: 4587111
• MDR Text Key: 5343612
• Report Number: 2520274-2015-11561
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2015

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: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LID FOR HANDPIECE DEVICE; BATTERY HANDPIECE DEVICE; POWER MODULE DEVICE; ADAPTOR DEVICE; LID FOR HANDPIECE DEVICE