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 Noise, Audible (3273); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had was making excessive noise and the trigger of the device was not moving smoothly.Therefore, the reported condition that the device was not working was confirmed.The assignable root cause of this condition was determined to be traced to component failure.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the battery handpiece device failed a lid leak tightness test, was making excessive noise, the trigger of the device was not moving smoothly, and the locking mechanism was stuck/stiff.It was further determined that the device failed pretest for check falling out protection (steal ring), check proper function of the triggers, check the attachment coupling, check for leakage, marking and labeling, and general condition.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.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 4437 ; SZ 4437
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9528648
• MDR Text Key: 193650780
• Report Number: 8030965-2019-71511
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 7611819977815
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• 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: 12/06/2019
• Date Manufacturer Received: 12/16/2019
• Date Device Manufactured: 06/04/2009
• 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