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

Catalog Number 05.001.201

Device Problems Break (1069); Leak/Splash (1354); Sticking (1597); Device Inoperable (1663); Component Missing (2306); Naturally Worn (2988)

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

Event Date 10/11/2016

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.The assignable root causes were determined to be due to improper cleaning/care and component wear from normal use over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the battery handpiece/modular device was broken.During in-house engineering evaluation, it was observed that the device did not function, would not engage and was seized.It was further determined that the trigger was sticking and the device failed the leakage test.It was observed that the disconnect sleeve was partially missing a yellow ring marking (chipped / worn off), and an unknown debris was on the internal components.It was determined that the housing was worn and the bearing was seized.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 6148370
• MDR Text Key: 62126025
• Report Number: 8030965-2016-15830
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 5532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2012
• 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