MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL MEDIUM TORQUE LIMITING HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.807.357
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
Occupation: initial reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 on an unknown date, the xrl medium torque limiting handle failed calibration.The issue was found during testing; there was no patient involvement.This report is for a torque limiting handle.This is report 1 of 1 for (b)(4).
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.Investigation summary - service and repair evaluation: the customer reported that xrl medium torque limiting handle had failed calibration.The repair technician reported that device failed the calibration during evaluation.The device minimum peak was at 0.50 nm which is less than the accepted torque range of 0.55 nm-1.00 nm.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.Device history lot - part # 03.807.357.Synthes lot # 1017.Serial number: 1017.Release to warehouse date: 22 nov 2011.Manufactured by synthes oberdorf.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: XRL MEDIUM TORQUE LIMITING HANDLE
• 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: 12528618
• Report Number: 2939274-2021-05751
• Device Sequence Number: 14283355
• Product Code: LXH
• UDI-Device Identifier: 10705034723303
• UDI-Public: (01)10705034723303
• 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
• Report Date (Section B): 08/27/2021

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: 03.807.357
• Device Catalogue Number: 03.807.357
• Device Lot Number: 1017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1