MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 60 DEG *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number	251723
Medical Device Problem Codes	Degraded (1153); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
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 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.H11 additional narrative: investigation summary = > the product was returned to depuy synthes for evaluation.Depuy synthes then conducted visual inspection of the device received.The device was received and evaluated.When performing the visual inspection, it could be observed that the device is in used condition, the shaft, wire, and handle do not show structural anomalies, however the needle is slightly bent.Also, the needle edge was found to be irregular on one of the sides.The device was able to be placed in closed, slip and open position.The overall complaint was confirmed as the observed condition of the ideal sutgrasper 60 deg *ea would have contributed to the complained issue.Based on the investigation findings, the potential cause for the device condition is traced to procedural variable, such as handling of the device or product interaction during procedure; excessive force was applied while the device was being inserted, therefore the device was damaged.As per ifu; excessive force while using this instrument for tissue approximation is not recommended and may result in damaging the device.Therefore, it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek 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.Device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.
Event or Problem Description
It was reported from hong kong that during a bankart repair procedure, it was discovered that the ideal sutgrasper 60 deg device was too blunt, preventing the surgeons from using it to penetrate the soft tissues.During in-house engineering evaluation, it was determined that the device was deformed/bent.There were no delays to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: 20136673
• Report Number: 1221934-2024-03054
• Device Sequence Number: 7305320
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: (01)10886705012312(10)247L324(17)281031
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: 251723
• Device Lot Number: 247L324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown