MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.632.204
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: reporter is a j&j sales representative.Investigation summary service and repair evaluation: the customer reported that the device failed torque test.The repair technician reported device failed torque testing and was out of calibration.The maximum torque peak attained during evaluation was 3.58 nm which is out of the specified limit 3.1 nm-3.5 nm for the part.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 torque.The item will be forwarded to customer quality.The evaluation was confirmed.Device history lot part # 03.632.204 synthes lot # h759867-03.Supplier lot # h759867-03.Release to warehouse date: 05 feb 2019.Supplier: avalign technologies-nemcomed.No ncrs were generated during production.Device history review 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 or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported on an unknown date that the device failed torque test.This report is for one (1) 3.0nm torq limiting hndl 4.5mm qk couplg.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.0NM TORQ LIMITING HNDL 4.5MM QK COUPLG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14633436
• Report Number: 2939274-2022-02130
• Device Sequence Number: 5937110
• Product Code: LXH
• UDI-Device Identifier: 10705034719535
• UDI-Public: (01)10705034719535
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/08/2022

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: 03.632.204
• Device Catalogue Number: 03.632.204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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