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

Catalog Number	511.771
Medical Device Problem Codes	Device Slipped (1584); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 most probable cause for the found issue was that the torque attachment device was used to unscrew or to remove the screws in the reverse mode, too much force was then applied to the device and as a result, the housing became loose and the internal parts were shifting back.Therefore, the assignable root cause was traced to improper handling which is user error.A device history review was performed, and no non-conformance's were detected related to the reported condition.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the torque attachment device would not work at all due to the internal parts of the device shifting back.This also made it impossible to insert the cutting tool device.During a visual inspection, it was observed that the thread of the housing came lose.It was noted in the service order that the thread of the housing of the torque attachment device became loose.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.

• 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: 11805340
• Report Number: 8030965-2021-03724
• Device Sequence Number: 17055446
• 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): 12/18/2020

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: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1