MAUDE Adverse Event Report: SYNTHES GMBH SOCKET WRENCH FOR VEPTR NUT

Model Number	03.641.004
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on unknown date, during evaluation, the repair technician found that the socket wrench for veptr nut failed calibration.The issue was found during testing at service and repair.No additional information available.This report is for one (1) socket wrench for veptr nut.This is report 1 of 1 for complaint (b)(4).
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.Reporter is a j&j employee.A product investigation was conducted.Service and repair evaluation: it was reported that during evaluation, the repair technician found that the device 03.641.004, socket wrench for veptr nut failed calibration.The issue was found during testing at service and repair.The repair technician reported that the device failed low for torque test during evaluation.The device minimum peak was at 4.864 nm which is lower than the accepted torque range of 5 nm- 6.4 nm.Torque test low is the reason for repair.The cause of the issue is torque test failed low.The item will be forwarded to customer quality.The evaluation was confirmed.A device history record (dhr) review was conducted: part # 03.641.004.Synthes lot # 9887049-11.Supplier lot # 9887049-11.Release to warehouse date: 07 jan 2016.Supplier: avalign technologies-nemcomed no ncrs 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: SOCKET WRENCH FOR VEPTR NUT
• Common Device Name: WRENCH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15629054
• Report Number: 8030965-2022-08388
• Device Sequence Number: 5983113
• Product Code: HXC
• UDI-Device Identifier: 10705034720128
• UDI-Public: (01)10705034720128
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 03.641.004
• Device Catalogue Number: 03.641.004
• Device Lot Number: 9887049-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown