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

Catalog Number 05.001.202

Device Problems Output Problem (3005); Temperature Problem (3022)

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

Event Date 02/27/2016

Event Type  malfunction  

Manufacturer Narrative

Reporter¿s phone number: (b)(6).The contact¿s complete address was not provided.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.

Event Description

It was reported from (b)(6) that before surgery, it was observed that the while using the drill device, the power module device became very hot and did not give the proper power.The reporter clarified that the user was trying the drill device before surgery when it was observed that the drill device was weak and started to get hot.The reporter stated that the power module device was replaced immediately and the device worked properly.The reporter stated that there was no allegation of malfunction against the drill device.There were no delays to the planned surgical procedure.A spare device was available for use.There was no patient involvement reported.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

The actual device was returned for evaluation.Reliability engineering evaluated the device and the device passed all the tests.The reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device casing /housing was cracked which was most likely caused by dropping.The assignable root cause was determined to be due to due to improper handling, which is user error/misuse/abuse.If information is obtained that was not available, 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 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: 5504292
• MDR Text Key: 40787970
• Report Number: 8030965-2016-11558
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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