MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.632.204
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The repair technician reported the device failed in calibration during service and repair evaluation.Torque test failed high is the reason for repair.The cause of the issue is unknown.The device was sent to the vendor for repair on 22-aug-2019.The vendor will repair the device per the vendor work instructions.The device will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 31.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 # 03.632.204.Synthes lot # h697388-16.Supplier lot # h697388-16.Release to warehouse date: 21 nov 2018.Supplier: (b)(4).No ncr's were generated during production.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.
Event or Problem Description
It was reported that on (b)(6) 2019, during testing at service and repair, a torque limiting handle with quick coupling failed in calibration.There was no patient involvement.This report is for one (1) 3.0 nm torque limiting handle with 4.5 mm quick coupling this is report 1 of 1 for (b)(4).

• Brand Name: 3.0NM TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9090332
• Report Number: 2939274-2019-60699
• Device Sequence Number: 11346163
• Product Code: LXH
• UDI-Device Identifier: 10705034719535
• UDI-Public: (01)10705034719535
• 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): 08/26/2019

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: 03.632.204
• Device Catalogue Number: 03.632.204
• Device Lot Number: H697388-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1