MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING; SCREWDRIVERS

Model Number 321.133

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter synthes employee.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 Description

It was reported that on (b)(6) 2019, during testing at service and repair, the torque limiting t- handle failed in calibration.There was no patient involvement.This is report 1 of 1 for (b)(4).

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: service & repair evaluation: during service and repair evaluation, the repair technician reported the device failed in calibration.The cause of the issue is unknown.The device was sent to the vendor for repair on 02-jan-2020.The vendor repaired the device per the vendor's work instructions.The device will be returned to the customer upon completion of the service and repair process.The finalized service record will be archived in the document management system.The evaluation was confirmed.Service & repair history: the previous service event for part number 321.133 with lot number(s) 7629900-02 has been reviewed.The customer called in a service request for this item on 5-dec-2019 for torque limiting t- handle failed in calibration.The item was previously returned for service on 25-apr-2016 due to tested high.The previous service condition of tested high is relevant to the current complained issue of torque limiting t- handle failed in calibration.The manufacture date of this item is 17-jun-2014.The service history review is 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 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: TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9537151
• MDR Text Key: 186727326
• Report Number: 2939274-2020-00001
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034769110
• UDI-Public: (01)10705034769110
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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
• Device Operator: Health Professional
• Device Model Number: 321.133
• Device Catalogue Number: 321.133
• Device Lot Number: 7629900-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 01/01/2020
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1