MAUDE Adverse Event Report: SYNTHES GMBH 10NM TORQ LIMITING RATCHET HANDL-6MM HXC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.620.061
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
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.Initial reporter occupation: is a j&j sales representative.Postal code (b)(6).Part # 03.620.061.Synthes lot # h881619-15.Supplier lot # h881619-15.Release to warehouse date # (b)(6) 2019.Supplier # avalign technologies-nemcomed.No non-conformance reports 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.Service and repair evaluation: it was reported that during routine incoming inspection of a loaner set, it was observed that a 03.620.061, 10nm torq limiting ratchet handl-6mm hxc had failed calibration.The repair technician reported device failed torque testing and was out of calibration.The minimum torque peak attained during evaluation was 9.67 nm which is out of the specified limit 10.2 nm- 11.8 nm for the part.Warranty replaced 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.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
It was reported that on unknown date, during evaluation, the repair technicians found that the device has failed calibration.Issue found during testing of service and repair.No further information.This report is for one (1) 10nm torq limiting ratchet handl-6mm hxc this is report 1 of 1 for complaint (b)(4).

• Brand Name: 10NM TORQ LIMITING RATCHET HANDL-6MM HXC
• 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 ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15419007
• Report Number: 8030965-2022-06802
• Device Sequence Number: 2785565
• Product Code: LXH
• UDI-Device Identifier: 10705034717784
• UDI-Public: (01)10705034717784
• 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: 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: 03.620.061
• Device Catalogue Number: 03.620.061
• Device Lot Number: H881619-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown