MAUDE Adverse Event Report: SYNTHES GMBH TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.835.043
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during evaluation on an unknown date, the repair technicians found that the torq limiting handle - 4.5mm qk coupling had failed in calibration.Issue was found during testing at service & repairs/monument.There was no patient involvement.No further information is available.This report involves one torque limiting handle with 4.5mm quick coupling.This is report 1 of 1 for (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.: part # 03.835.043.Synthes lot # 1952720116.Supplier lot # 1952720116.Release to warehouse date: 05 may 2022.Supplier: (b)(4).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.It was reported that during routine incoming inspection of a loaner set, it was observed that a 03.835.043, torque limiting handle with 4.5mm quick coupling had failed calibration.The repair technician reported that device failed torque test in service and design limits and required further testing at the vendor.The cause of the issue is torque test failed low.The vendor reported that the device attained minimum torque peak which was less than the accepted torque range for the part.The item will be repaired and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore 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: TORQUE LIMITING HANDLE WITH 4.5MM QUICK COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15851349
• Report Number: 8030965-2022-10206
• Device Sequence Number: 5076837
• Product Code: LXH
• UDI-Device Identifier: 10705034817569
• UDI-Public: 10705034817569
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 03.835.043
• Device Catalogue Number: 03.835.043
• Device Lot Number: 1952720116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown