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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

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.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the device was too loud and made harsh sounds during use was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had a sticky trigger.The assignable root cause was determined to be traced to maintenance.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported by germany that during service and evaluation, it was determined that the battery handpiece device had seized bearing, leak tightness test failure, sticky trigger, would not run, would not hold/secure battery and had cracked/damaged housing.It was further determined that the device failed pretest for general condition, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers, check roundness of housing, check falling out protection (steel ring), check fitting of the lid, check for wear on housing and check general function of device.It was noted in the service order that during pre-surgery, it was discovered that the device was too loud and made harsh sounds during use.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.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 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: 18789073
• MDR Text Key: 337075774
• Report Number: 8030965-2024-02861
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 02/12/2024
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1