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)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only event year is known.Reporter is a synthes employee.The device has been 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) 2020, during evaluation at service and repair, an xrl medium torque limiting handle failed calibration.There was no patient involvement.This report involves one (1) xrl medium 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.H10 additional narrative: h3, h6: part: 03.807.357.Lot: 1314.Manufacture date of this item is december 8, 2015 a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.Visual inspection: the xrl medium torque limiting handle was returned and received at us customer quality (cq).Upon visual inspection, no issues were observed with the returned device.Functional test: a functional test was performed during service and repair evaluation.The low torque of the device measured during calibration testing was not within the specified torque range of the device.Hence, the torque test failed low.Service and repair history: the previous service event for part 03.807.357 with lot 1314 has been reviewed.The customer called in a service request for this item on december 16, 2020 for failed calibration.The item was previously returned for service on april 18, 2016 due to eval test ok.The previous service condition of eval test ok is not relevant to the current complained issue of failed calibration.The manufacture date of this item is december 8, 2015.The service history review is unconfirmed.Service and repair evaluation: during evaluation at service and repair, an xrl medium torque limiting handle failed calibration.The repair technician reported the device failed torque testing.The item is not repairable per the inspection sheet.The cause of the issue is failed low.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Torque limiting driver.Synthes loaner set product specific inspection and verification instructions.Investigation conclusion the complaint condition was confirmed for the xrl medium torque limiting handle.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 11155728
• Report Number: 2939274-2021-00210
• Device Sequence Number: 3980011
• 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): 12/16/2020

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: 03.807.357
• Device Catalogue Number: 03.807.357
• Device Lot Number: 1314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1