MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS

Model 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: reporter is a j&j employee.A product investigation was conducted.Service & repair evaluation it was reported that during the evaluation, the technicians found out that the device failed its calibration.The issue was found during testing at the service and repair.The repair technician reported the device failed torque testing.The cause of the issue is failed low.The device will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part number: 03.602.042, synthes lot number: 9911964-07, supplier lot number: 9911964-07, release to warehouse date: 20-aug-2016, supplier: s.S.White medical products, no ncrs were generated during production.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.
Event or Problem Description
It was reported that during the evaluation, the technicians found out that the device failed its calibration.The issue was found during testing at the service and repair.No patient involvement, no patient consequence.This report is for one (1) 12nm torque limiting wrench for dual-opening uss.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12374908
• Report Number: 2939274-2021-04961
• Device Sequence Number: 11737866
• Product Code: HXC
• UDI-Device Identifier: 10705034712277
• UDI-Public: (01)10705034712277
• 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
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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 Model Number: 03.602.042
• Device Catalogue Number: 03.602.042
• Device Lot Number: 9911964-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1