MAUDE Adverse Event Report: SYNTHES GMBH Q-COUPLING FOR KWIRES AND PINSØ1.5-4.0MM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.791

Device Problem Mechanical Jam (2983)

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

Event Date 08/12/2023

Event Type  malfunction  

Event Description

It was reported by india that during service and evaluation, it was determined that the quick coupling device was frozen/would not move.It was further determined that the device failed pretest for check function in running mode.It was noted in the service order that the device was stuck, and the battery casing was nonfunctional.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 become available, a supplemental medwatch will be submitted accordingly.

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.H10 additional narrative: d10: concomitant med products and therapy dates: battery casing device, (b)(6) 2023 device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device being frozen/would not move, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from wear.Udi: (b)(4).

• Brand Name: Q-COUPLING FOR KWIRES AND PINSØ1.5-4.0MM
• 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: 18139102
• MDR Text Key: 328148485
• Report Number: 8030965-2023-14355
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491861
• UDI-Public: 07611819491861
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1