MAUDE Adverse Event Report: SYNTHES GMBH 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS

Model Number 03.602.042

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during evaluation on an unknown date, the repair technicians found that this device failed calibration.The issue was found during testing at service and repair.No further information is available.This report involves one 12nm torque limiting wrench for dual-opening uss.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.Reporter is a j&j employee.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.

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.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.Part # 03.602.042, synthes lot # h207652-04, supplier lot # h207652-04, release to warehouse date # 17 nov 2016, supplier # (b)(4), no ncrs were generated during production.Service and repair evaluation: it was reported that during routine incoming inspection of a loaner set, it was observed that a 03.602.042, 12nm torque limiting wrench for dual-opening uss had failed calibration.The repair technician reported that the device failed torque test in counterclockwise direction.The minimum torque peak attained during evaluation in counterclockwise direction was outside of the specified limit of the part.Torque test low is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is torque test failed low.The item will be forwarded to customer quality.The evaluation was confirmed.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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.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: 12NM TORQUE LIMITING WRENCH FOR DUAL-OPENING USS
• Type of Device: 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15851255
• MDR Text Key: 307695583
• Report Number: 8030965-2022-10204
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034712277
• UDI-Public: 10705034712277
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 03.602.042
• Device Catalogue Number: 03.602.042
• Device Lot Number: H207652-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 12/19/2022
• Supplement Dates FDA Received: 11/29/2022; 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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