MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.201

Device Problems Device Stops Intermittently (1599); Detachment of Device or Device Component (2907)

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

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the deck on the battery handpiece device opened up and the power module device fell out.According to the reporter, the trs was sterilized and tests were performed and it was still possible to open the deck without applying too much force after turning it to lock.It was unknown if there were delays to the surgical procedure or if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however it was noted that the event occurred in 201.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The date of this report and the date received by manufacturer were documented as may 18, 2018 in the initial report.These dates have been updated to may 15, 2018.If additional information should become available, a supplemental medwatch report will be sent accordingly.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the battery handpiece device failed pretests for general condition, check for leakage and check fitting of the lids.It was further determined that the bar inside the housing which locks the lid was broken off, the housing was oval and leaky, the front plate was discolored and the anodizing was partly missing.Additionally, the pick-up coupling started to rust and the yellow marking ring on disconnect sleeve started pealing off.After the pre-test the device was disassembled and it was found that the spiral bevel gear had tempering colors changing from brownish to dark blue, which was due to overheating, and the seals inside of the housing were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time and improper handling of the device.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The serial number of the device was documented as unknown in the initial medwatch report.This has been updated to (b)(4).The unique identifier( udi) has been updated accordingly.Concomitant device added.The manufacturing site name and address were documented as unknown in the initial medwatch report.The location has been updated to (b)(4).The manufacture site name/address has been updated accordingly to reflect the updated manufacturing facility.The device manufacture date was reported as unknown in the initial medwatch report.This has been updated to dec 04, 2015.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.It was inadvertently documented in the initial report that the exact date of the event was not reported, however it was noted that the event occurred in 201.Upon complaint review, it was determined that the event occurred in 2017.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.During further evaluation, it was observed that the device had fluid ingress; the inner part of the device that should have been sealed off exhibited signs of liquid.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf ; SZ
• MDR Report Key: 7592935
• MDR Text Key: 110851010
• Report Number: 8030965-2018-54287
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819977815
• UDI-Public: (01)7611819977815
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.201
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LID DEVICES