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

Model Number 03.641.004

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is synthes employee.A product investigation was conducted.Visual inspection: the socket wrench for veptr nut (p/n: 03.641.004, lot # 6965081-03) was returned and received at us cq.Upon visual inspection, there were scratches and the etch on the device started to fade which has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Functional test: the functional test was performed on the returned device at service and repair.The highest torque of the device measured during calibration testing was 6.891 nm which was not within the specified torque range of the device of 5.0 nm - 6.4 nm per ps063839, rev.M.Hence, the torque test failed high.The complaint can be replicated with the returned device.Service & repair evaluation: during service evaluation, the repair technician reported the socket wrench has failed in calibration.The item is not repairable per the inspection sheet.The cause of the issue is the device failed high.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint device failed in the calibration test.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed.Investigation conclusion: the complaint condition is confirmed as the socket wrench for veptr nut (p/n: 03.641.004, lot # 6965081-03) failed high in the calibration test.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: part #: 03.641.004, synthes lot number: 6965081, supplier lot number: 6965081.Release to warehouse date: 23-jul-2012, supplier: (b)(6), manufacturing site: synthes (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.

Event Description

It was reported that on (b)(6) 2019, during testing at service at repair, a socket wrench failed in calibration.There was no patient involvement.This is report 1 of 1 for complaint (b)(4).

• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9468955
• MDR Text Key: 194454264
• Report Number: 2939274-2019-62664
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034720128
• UDI-Public: (01)10705034720128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 6965081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1