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

Catalog Number 05.001.201

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported from (b)(6) that the battery handpiece device was not working in reverse and making a noise.This event did not occur during surgery.There was no 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 will be submitted accordingly.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device failed pretest for check status of development, check proper function of the triggers, and check of free moving.It was noted that the bearings were not function and were defective on the device and the reverse trigger was faulty.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted 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 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA ; 6107195000
• MDR Report Key: 7120081
• MDR Text Key: 95196504
• Report Number: 8030965-2017-50712
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819977815
• UDI-Public: (01)7611819977815(11)131025
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXMEPT
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1