MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SOCKET WRENCH FOR VEPTR NUT

Model Number 03.641.004

Device Problem Failure to Calibrate (2440)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).Without a lot number, the device history records review could not be completed as no product was received.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 Description

It was reported on an unknown date that the socket rench was failed calibration.There was no surgery or patient involved.This report is for one (1) socket rench.This is report 1 of 1 for (b)(4).

Event Description

It was reported on may 28, 2020, during testing at service and repair, the technician found that the socket wrench for veptr nut failed in calibration.There was no patient involvement.This report is for one (1) socket wrench for veptr nut.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: correction: b5.H6: patient codes.Additional information: d4: lot.H3, h6: part number:03.641.004, synthes lot number: h130932-23, supplier lot number: n/a, release to warehouse date: october 19, 2016, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the socket wrench for veptr nut (part # 03.641.004 / lot # h130932-23) was received at us customer (cq).Besides normal surface wear, no visual defects were identified with the returned device.Service and repair evaluation: the customer reported the device failed calibration.The repair technician reported the device failed the torque test.Torque test high is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is failed high.The item will be forwarded to customer quality.The evaluation was confirmed.Functional test: functional testing was performed by service and repair.While being functionally tested, the socket wrench tested high at 7.88nm which was not within the specified torque range of the device of 5.0 nm - 6.4 nm.The overall complaint was confirmed as the wrench was out of calibration and tested high.It was also identified at service and repair that the device was over 3 years old thus not repairable.Dimensional inspection: dimensional inspection was not performed as internal components were not accessible without device destruction.Document/specification review: drawing(s) reviewed: current & manufactured socket wrench.Depuy/synthes torque handle testing calibration verification.It was identified that the returned instrument has exceeded the expected instrument life (three years) established by bradshaw, therefore any recalibration could not be assured.Conclusion: the complaint condition is confirmed as the socket wrench for veptr nut failed calibration.The returned instrument has exceeded the expected instrument life (three years) established by bradshaw, therefore any recalibration could not be assured.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, 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: SOCKET WRENCH FOR VEPTR NUT
• Type of Device: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10133310
• MDR Text Key: 194492431
• Report Number: 2939274-2020-02718
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034720128
• UDI-Public: (01)10705034720128
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.641.004
• Device Catalogue Number: 03.641.004
• Device Lot Number: H130932-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1