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

Catalog Number 251723

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2024

Event Type  malfunction  

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.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.H10 additional narrative: e3: reporter is a j&j sales representative.D4, h4: the device expiration date and date of manufacture are unknown at this time.(b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep in japan that during an anterior rotator cuff repair procedure on (b)(6) 2024 the ideal sut grasper 60 deg *ea device had a permatape inserted into the humeral head.The suture grasper in question was used when applying the loaded permatape to the rotator cuff.When the tape was applied to the rotator cuff using the suture grasper in question, the tape did not slide smoothly within the anchor.It caused a strong resistance.The clip mechanism in the suture grasper failed and partially broke off.After the procedure was completed, the image showed that the broken piece remained inside the body before the wound was closed.The surgeon determined that removal was not possible and that the possibility of health hazard was extremely low, so that the surgery was completed.The surgery was completed successfully within 30 minutes delay.According to the surgeon, if permatape is applied to the rotator cuff using a suture grasper, there is a very high risk that the clips in the suture grasper will break off due to the resistance of the tape.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 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.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.H10 additional narrative: d4, h4: the device expiration date and date of manufacture were unknown in the initial report and have been updated accordingly.The device udi has also been updated.Udi: (b)(4) the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances related to the reported complaint condition were identified.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: 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: 18889269
• MDR Text Key: 337742200
• Report Number: 1221934-2024-00822
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 251723
• Device Lot Number: 220L100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1