MAUDE Adverse Event Report: SYNTHES GMBH TORQUE LIMITING ATTACHMENT 4NM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	511.771
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 history review: a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Device evaluation: the actual device was returned for evaluation.  quality engineering evaluated the device and it was determined that the reported condition was confirmed.It was noted that the attachment device was likely used for unscrewing and due to lack of maintenance, the glue bonding loosened and as a consequence the tool coupling and the main body unscrewed.It was further noted that service was overdue.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the attachment device failed visual inspection.It was determined that the device was received fallen apart and the tool coupling and the main body had unscrewed.It was further determined that the device failed pretest for general condition and check the torque.The device was reassembled for assessment of the torque unit and all torque measurements passed.It was noted in the service order that halfway through an unspecified surgical procedure, it was observed that the torque limiter was spinning and no longer worked.It was reported that there was a minimal time delay to the surgical procedure.A spare device was used to complete the surgery without any issues.There was patient involvement reported.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 report will be submitted accordingly.

• Brand Name: TORQUE LIMITING ATTACHMENT 4NM
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12434530
• Report Number: 8030965-2021-07337
• Device Sequence Number: 3255191
• Product Code: GEY
• UDI-Device Identifier: 07611819119376
• UDI-Public: 07611819119376
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 511.771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1