MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5NM TORQUE LIMITING NUT DRIVER; SCREWDRIVER

Model Number	03.615.040
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
Reporter is a synthes employee.A dhr was performed on the serviceable device and it was found that the device was manufactured on december 11, 2017.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.Service and repair evaluation: the customer reported that the torque limiting nut driver failed in calibration.The repair technician reported the device failed torque testing.The cause of the issue is failed high.The item will be repaired and will be returned to the customer upon completion of the service and repair process.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.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 testing at service and repair on (b)(6) 2021, the torque limiting nut driver failed in calibration.There was no patient and surgical involvement.This report involves one (1) 2.5nm torque limiting nut driver.This is report 1 of 1 for (b)(4).

• Brand Name: 2.5NM TORQUE LIMITING NUT DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11589404
• Report Number: 2939274-2021-01593
• Device Sequence Number: 11807868
• Product Code: HXX
• UDI-Device Identifier: 10705034715339
• UDI-Public: (01)10705034715339
• 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): 03/03/2021

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: 03.615.040
• Device Catalogue Number: 03.615.040
• Device Lot Number: H305973-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1