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

Catalog Number 05.001.201

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the handpiece device and the reported condition that the device was making an unexpected noise and would not run was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the lower trigger of the device was sticky.Furthermore, the device failed tightness test.The assignable root cause of these conditions was determined to be traced to component failure due to wear.The reported condition of not running device and unexpected noise could be traced back to a problem of the power unit.A review of the device history was performed and no non-conformances were detected related to the reported condition.

Event Description

It was reported from switzerland that during service and evaluation, it was determined that the lower trigger of the handpiece device was sticky, the device failed tightness test.It was further determined that the device failed pretest for leakage test, check for sticky triggers, and check function of new version falling out protection.It was noted in the service order from japan that during an open reduction internal fixation (orif), the operation of the handpiece was checked and was confirmed to work properly.However, before the surgery, when the nurse inserted a fully charged battery into the handpiece, it did not respond.Operation was confirmed in all modes, but the handpiece did not respond.The nurse replaced the battery with a spare, but it still did not respond in all modes.When the nurse held the handpiece in question close to her ear while pressing the trigger, she could hear the slight sound of the motor, but it did not move properly, so the surgery was performed using the hospital's own power tools.After the surgery, a sales rep checked the device's operation, but could only hear a slight motor noise, confirming that it was not working properly.It was reported that the surgery was completed successfully without any surgical delay.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.

• 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
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 18324563
• MDR Text Key: 330482583
• Report Number: 8030965-2023-15686
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 07611819977815
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 11/09/2023
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• 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