MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC XRL LARGE TORQUE LIMITING HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	03.807.358
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2018, during testing at service and repair, a large torque limiting handle failed in calibration.There was no patient involvement.This complaint involves one (1) device.
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.H3, h6: a product investigation was conducted.Service and repair evaluation: during service and repair the repair technician reported a large torque limiting handle failed in calibration.The repair technician reported the device failed low in torque test.Torque test failed low is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Visual inspection: the xrl large torque limiting handle (p/n 03.807.358 lot 1118) was received at customer quality, and it is observed that there is no visual damage except a few scratches which would not contribute to the complaint condition.Functional test: the repair technician reported the device failed in calibration.Torque test failed low is the reason for repair.Per drawing, the wrench shall have a torque limiting value of 0.8 +0.2/-0.05 nm.The device fell lower than the low end of the allowable torque range on 1 of the 24 clockwise tests.The observed condition is not able to be replicated at us cq, however, the complaint condition is confirmed per the service and repair evaluation and attached report.Document/ specification review: the relevant drawing(s) was reviewed.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation conclusion: the complaint condition is confirmed as the xrl large torque limiting handle (p/n 03.807.358 lot 1118) was returned after failing calibration.Visual inspection, document/specification review and functional test were performed as part of this investigation.The complaint condition of ¿failed calibration¿ was confirmed.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.807.358, synthes lot number: 1118, manufacturing site: oberdorf, release to warehouse date: 20.July 2017.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 LARGE TORQUE LIMITING HANDLE
• 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: 9147561
• Report Number: 2939274-2019-61132
• Device Sequence Number: 2830985
• Product Code: LXH
• UDI-Device Identifier: 10705034723310
• UDI-Public: (01)10705034723310
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 03.807.358
• Device Catalogue Number: 03.807.358
• Device Lot Number: 1118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1