MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TORQUE-LIMITING HANDLE 12NM F/USS-II; SURGICAL INSTRUMENT HANDLE, TORQUE-LIMITING

Catalog Number	03.602.042
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 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.Reporter is a j&j sales representative.
Event or Problem Description
It was reported by the sales rep that during in-house service repair and evaluation, it was determined that the torque limiting handle device failed calibration.There was no procedure nor patient involvement reported.No additional information was provided.This complaint involves one (1) device.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6 investigation summary service and repair evaluation: the customer reported the repair technicians found that this device failed calibration.The repair technician reported device failed torque testing.The minimum torque peak attained during evaluation was 13.33 nm which is out of the specified limit 12 nm-13 nm for the part.Torque test high is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is torque test high.The item will be forwarded to customer quality.The evaluation was confirmed.Device history part# 03.602.042 synthes lot# h207652-10 supplier lot# h207652-10 release to warehouse date: 14 apr2017, 17 may2017 supplier: (b)(4) nr-0055082 was generated during production for torque limiting wrench.This non-conformance is not relevant to the complaint condition since the device failed calibration.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H11: corrected data: d9, h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.

• Brand Name: TORQUE-LIMITING HANDLE 12NM F/USS-II
• Common Device Name: SURGICAL INSTRUMENT HANDLE, TORQUE-LIMITING
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14488933
• Report Number: 2939274-2022-01909
• Device Sequence Number: 5321634
• Product Code: HXC
• UDI-Device Identifier: 07611819995512
• UDI-Public: 07611819995512
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 03.602.042
• Device Lot Number: H207652-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 06/15/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/14/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown