MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Catalog Number	251004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the healthcare professional in australia that during an arthroscopic stabilization procedure on (b)(6) 2023, it was observed that the weld on the end of the ideal suture shuttle 45 degrees right device came apart then a sharp piece extended out.According to the report, the surgeon was still able to finish the procedure with the device.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Investigation summary: two photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Visual analysis of the photos revealed that the device tip condition could not be noted.The handle and the sleeve appear to be in good shape.A partial part of the needle shaft is out of the sleeve.The shuttle is completely out of the device.A manufacturing record evaluation was performed for the finished device and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection of the photo, this complaint can be confirmed.A possible root cause for the reported issue can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive force may have been applied to the needle and consequently make the needle shaft move from its corresponding position, however, this cannot be conclusively determined.As per the instructions for use, do not apply excessive axial or bending forces to the needle shaft or shuttle during use, as excessive force may limit the function of the device or cause the device to bend, deform or break.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: IDEAL SUTURE SHUTTLE 45 DEGREES RIGHT
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17427416
• Report Number: 1221934-2023-02865
• Device Sequence Number: 5931728
• Product Code: HCF
• UDI-Device Identifier: 10886705011650
• UDI-Public: 10886705011650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Operator of Device: Health Professional
• Device Catalogue Number: 251004
• Device Lot Number: 23B07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/20/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown