MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS LID F/BATT-HANDPIECE NO. 05.001.201 F/TR; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.227

Device Problems Vibration (1674); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.It was determined that the failure was due to the device used without following the duty cycles requirements which caused the damage to the device.It was determined that the lack of tightness was a result of damaged housing of the trs handpiece.It was determined that too long duty cycles or worn out cutter devices (reduced cutting performance) caused the heating, which lead to the damage to the device.It was further determined that vibrations were normal feature of the trs system, until the duty cycles were respected.It was determined that in the case of reported trs devices, too long vibrations caused overheating and damage to the devices.It was further observed that the knob of the lid device was found to be blocked due to groove deformation at the magnet holder area.

Event Description

This is report 2 of 2 for the same event: it was reported from (b)(6) that at the end of surgery, it was discovered that the lid of the battery handpiece device was stuck and could not be opened to remove the power module device.It was reported that the patient's wound was already closed when the issue was observed.During in-house engineering evaluation, it was observed that the lid device had lack of tightness which caused the damage of the housing of the trs handpiece device.It was further determined that the device overheated and was vibrating.It was reported that there were no delays in surgery as the intervention was over.It was reported that the event occurred at the end of surgery, inside of the operating room, before the device was returned to the sterilization/washing area.According to the reporter, it was mandatory to remove the battery device before returning the device to sterilization.There was no impact to the patient.There was no patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LID F/BATT-HANDPIECE NO. 05.001.201 F/TR
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6171180
• MDR Text Key: 62457728
• Report Number: 8030965-2016-15905
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.227
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2010
• 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
• Treatment: BATTERY HANDPIECE DEVICE; BATTERY DEVICE; POWER MODULE DEVICE