MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5NM TORQUE LIMITING HANDLE 6MM HXC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.641.002
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part number: 03.641.002, synthes lot number: 6607688, supplier lot number: n/a, release to warehouse date: june 2, 2011, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.It was reported on (b)(6), 2020, during evaluation at service and repair it was found out that the torque limiting handle had failed in calibration.The repair technician reported the device failed calibration.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.Attached service record router completed through operation 10.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 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 on (b)(6) 2020, during evaluation at service and repair it was found out that the torque limiting handle had failed in calibration.There was no patient involvement.This report involves one (1) 5nm torque limiting handle 6mm hxc.This is report 1 of 1 for (b)(4).

• Brand Name: 5NM TORQUE LIMITING HANDLE 6MM HXC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10408288
• Report Number: 2939274-2020-03541
• Device Sequence Number: 11401267
• Product Code: LXH
• UDI-Device Identifier: 10705034720104
• UDI-Public: (01)10705034720104
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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 Model Number: 03.641.002
• Device Catalogue Number: 03.641.002
• Device Lot Number: 6607688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1