MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2NM TORQUE LIMITING HANDLE - QK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.614.035
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
Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review /investigation but has yet to be received.Initial reporter occupation: reporter is a j&j sales representative.The investigation could not be completed, no product was received; 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 on (b)(6) 2021, during evaluation at service and repair it was found out that the socket wrench had failed in calibration.There was no patient involvement.This complaint involves one (1) device.This report is for (1) 2nm torque limiting handle - qk coupling.This report is 1 of 1 (b)(4).
Event or Problem Description
It was reported that during evaluation at service and repair it was found out that the 2nm torque limiting handle had failed in calibration.There was no patient involvement.
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: the customer reported failed in calibration.The torque tested low.The device was tested at service and repair center and the item was sent to the supplier on 04-may-2021 for repair.The cause of the issue is failed low.The item will be repaired per the inspection sheet and will be returned to the customer upon completion of the service and repair process.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.H3, h6: a device history record (dhr) review was conducted: part # 03.614.035, synthes lot # h686587-01, supplier lot # h686587-01, release to warehouse date: 16 oct 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.

• Brand Name: 2NM TORQUE LIMITING HANDLE - QK 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: 11886398
• Report Number: 2939274-2021-02594
• Device Sequence Number: 14389591
• Product Code: LXH
• UDI-Device Identifier: 10705034715032
• UDI-Public: 10705034715032
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 03.614.035
• Device Catalogue Number: 03.614.035
• Device Lot Number: H686587-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1