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 a j&j employee.A product investigation was conducted.Visual inspection: the socket wrench for veptr nut (p/n: 03.641.004, lot #: 7934215-04) was returned and received at us cq.Upon visual inspection, no issues were identified with the returned 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 and was not within the specified torque range of the device.Hence, the torque test failed high.Service and repair history: the previous service event for part number 03.641.004 with lot number(s) 7934215-04 has been reviewed.The customer called in a service request for this item on 3-aug-2020 for failed calibration.The item was previously returned for service on out of specification due to.The previous service condition is relevant to the current complained issue of failed calibration.The manufacture date of this item is 11-jun-2015.The service history review is confirmed.Service and repair evaluation: during an evaluation at service and repair, it was found out that the socket wrench failed in calibration.The repair technician reported the device failed calibration.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.Document/specification review: based on the date of manufacture, reflecting the current and manufactured revision drawings were reviewed and no design/manufacturing issues were identified.Investigation conclusion: the complaint condition is confirmed as the socket wrench for veptr nut (p/n: 03.641.004, lot #: 7934215-04) failed high in torque test.There is no indication that a design or manufacturing issue has caused the breakage 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.A device history record (dhr) review was conducted: part number: 03.641.004, lot number(s) 7934215-04, per service and repair history, manufactured date: 11-jun-2015.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 during evaluation at service and repair it was found out that the socket wrench 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).

• 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: 10459968
• MDR Text Key: 204603600
• Report Number: 2939274-2020-03817
• 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: 08/03/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.641.004
• Device Catalogue Number: 03.641.004
• Device Lot Number: 7934215-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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