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

Catalog Number 05.001.201

Device Problem Noise, Audible (3273)

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

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The manufacturing location was unknown, device manufacture date was unknown.Reporter¿s complete mailing address was not provided.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 the battery handpiece device was making a loud sound.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2019.All available has been disclosed.If additional information were to 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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device bearing and gear were worn.The device also failed pretest for check of free moving.Therefore, the reported condition was confirmed.The assignable root cause was traced to component failure.A service history review was performed, and no non-conformances were detected related to the reported condition.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.The manufacturer location was documented as unknown in the initial report.The location has been updated to waldenburg.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.The device manufacture date was documented as unknown in the initial report.It has been updated to april 03, 2013.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : all the investigation related information / activities / actions are in pi-(b)(4).This record pi-(b)(4) has been automatically generated from the system upon completing the work order.,sc identified following condition : internal finding : worn bearing, comments from technician : bearing worn and gear worn.Failure reported by the affiliate has been confirmed.The device failed following inspection criteria during pretest : check of free moving.The service technician noted the following action taken: _repair.The service history review shows that the previous service condition from 3-apr-2019 is not relevant to the current complaint issue.Technician note : bearing worn and gear worn, change all faulty parts, tested working fine.The device has been serviced and functional testing has been performed in accordance with the service manual se_113221 au.05.001.201_the service technician identified the probable root cause: _cause traced to component failure device history review : null,due to positive service history, dhr review only covers the related service records.Service history record review result is not relevant to the current complaint and/or service process findings this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: corrected data, d10, the date the device was returned to the manufacturer was reported as september 13, 2019 in the initial report and has been updated to december 27, 2019.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9104032
• MDR Text Key: 159604674
• Report Number: 8030965-2019-68471
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 07611819977815
• 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
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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: 12/27/2019
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1