MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LID F/NO. 05.001.201 MOD F/TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.231

Device Problem Device Slipped (1584)

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

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was returned and is currently pending evaluation.Once reliability engineering evaluates the device, a follow-up medwatch will be submitted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 of the same event.It was reported from france that during an unspecified surgical procedure, it was observed that it was difficult to lock the cover (lid) device on the battery hand piece device.It was further reported that the surgeon was unable to lock the lid and activate the lever to saw.There was an approximately thirty minute delay to the planned surgical procedure to retrieve a spare device.The surgical procedure was continued with the spare device.There was 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

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the lid was cracked and leaking.Therefore, the reported condition was confirmed.It was determined that the crack in the lid was typical for a damage caused by dropping the device.It was determined that the lock-device can be switched from "lock" to "unlock position" without pressing the push-button.It was determined that this was assessed as a subsequent damage due to handling difficulties.The assignable root cause was determined to be due to faulty product construction/design and faulty handling.This issue has been escalated to capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LID F/NO. 05.001.201 MOD 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: 5197758
• MDR Text Key: 30523167
• Report Number: 3009450871-2015-13971
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• 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