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

Catalog Number	511.771
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
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.The serial number is currently unavailable.Device manufacture date: the device manufacture date is currently unavailable as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: serial number unknown; (b)(4).
Event or Problem Description
It was reported from the (b)(6) that the torque limiting attachment device unscrewed when using anti clockwise.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.
Additional 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: d4: serial number: the serial number was unknown in the initial report.The lot number has been updated as 8151.H4: the device manufacture date was reported as unknown in the initial medwatch report.This has been updated to dec 19, 2014.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.Udi: (01)07611819119376(21)8151.
Additional 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.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the torque limiting attachment device unscrewed when using anti clockwise was not confirmed.Therefore, an assignable root cause for the reportable condition was not determined.However, during evaluation, it was determined that the device had vibration-untrue running and component damage.It was further determined that the device failed pretest for check the untrue running.It was noted that the device ran unevenly.The assignable root cause was determined to be due to component failure from wear.Correction: device availability: d9: the device availability date was incorrect in the initial report.The date has been updated from 8/20/2021 to 8/31/2021.

• 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: 12170174
• Report Number: 8030965-2021-05706
• Device Sequence Number: 19883542
• Product Code: GEY
• UDI-Device Identifier: 07611819119376
• UDI-Public: 07611819119376
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2021

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: 08/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/20/2021; 09/06/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/26/2021; 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1