MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 90 DEGREES; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Catalog Number	251005
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.The product was not returned to j&j medtech orthopaedics, however a photo was provided for evaluation.Visual inspection of the returned photo found that the device is shown in used condition.In addition, the needle and the nitinol wire were found bent.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the ideal suture shuttle 90 degrees would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.Based on the device condition, the possible root cause can be associated with applying an excessive force to the suture shuttle during use of the device.As per ifu, 1) 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.2) a damaged or broken device may result in extended or additional surgeries or residual foreign bodies.3) inspect the ideal suture shuttle and shuttle prior to use to ensure proper mechanical function.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.¿.
Event or Problem Description
It was reported that during a rotator cuff repair surgery, it was observed that the ideal suture shuttle 90 degrees device was deformed.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: IDEAL SUTURE SHUTTLE 90 DEGREES
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 23477348
• Report Number: 1221934-2025-04223
• Device Sequence Number: 16083706
• Product Code: HCF
• UDI-Device Identifier: 10886705011667
• UDI-Public: (01)10886705011667(10)24J07(17)290122
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 251005
• Device Lot Number: 24J07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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