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 Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

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 reported condition that the device was leaking liquid was confirmed.However, the assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported from the (b)(6) that during evaluation of the battery handpiece device, it was determined that the device was leaking liquid.It was noted that the device had a worn tool coupling nose, the driving shaft was damaged, and the device did not pass the leakage test.It was further determined that the device failed pretest for check falling out protection (steal ring), check the cannulation, check for leakage, and marking and labeling.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, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted 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.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

H10: depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Correction: upon further review of the device evaluation, additional information was obtained.The reporter clarified that the event was coded incorrectly during evaluation.The analysis codes have been updated from functional: leak - liquid to internal finding: lid leak tightness test failure since there was no evidence of liquid leaking out of the device.The code of lid leak tightness test failure does not meet the criteria of a reportable malfunction and is unlikely to cause or contribute to a serious injury.Therefore, the initial medwatch report was submitted in error.No further investigation will be performed at this time.

• 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
• MDR Report Key: 9162662
• MDR Text Key: 196208981
• Report Number: 8030965-2019-69100
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 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
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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: 08/28/2019
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1