MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 30 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 251721

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

This is report 2 of 2 for (b)(4).It was reported by a healthcare professional in singapore that during an unknown procedure on (b)(6) 2022, it was observed that the wire tip on the 30° suture grasper device broke while the surgeon was trying to extract the handle out.According to the report, the device was used to penetrate through labral tissue.Changed to another one but the same issue happened again.It was reported that the surgeon tried to scope around to look for the missing 3mm wire but unable to locate it; and therefore, the surgeon ordered for a post op x-ray to be conducted.It was reported that the patient was in stable condition.There were no adverse patient consequences reported.No additional information was provided.

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.Udi: (b)(4).Patient identifier: (b)(6).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.

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 fied as appropriate.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it appeared that tip was broken.Based on the condition, this complaint reported was confirmed.A manufacturing record evaluation was performed for the finished device 8l94582, and no non-conformances were identified.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.A definite root case cannot be determined for this failure.The damages are associated with levering during insertion or excess tension applied on inserter which caused damage.However, it cannot be conclusively affirmed.As per ifu, excessive force while using this instrument for tissue approximation is not recommended and may result in damaging the device.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot that was released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• 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: 16055304
• MDR Text Key: 308184261
• Report Number: 1221934-2022-04237
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 251721
• Device Catalogue Number: 251721
• Device Lot Number: 8L94582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Male