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

Catalog Number 251723

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

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.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.H10 additional narrative: h4: the device manufacture date is unknown.Udi:(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 affiliate in japan that during an unknown procedure on (b)(6).2023 the ideal sutgrasper 60 deg device hook did not return to its original position after the surgeon inserted the device into the rotator cuff, exposed the hook, and retrieved a suture advancing the thumb slide.It was reported that the surgeon removed the device as it was and operated the thumb slide, but the hook still did not return to its original position.Another like device was used to complete the procedure.There was no delay in the procedure reported.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 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.The investigation has been updated to reflect the correct information: investigation summary: according to the information provided.It was reported, that "the surgeon inserted the device into the rotator cuff, exposed the hook and retrieved a suture advancing the thumb slide.The surgeon operated the thumb slide.But, the hook did not return to its original position.The surgeon removed the device as is.And operated the thumb slide.But, the hook still did not return to its original position".The complaint device is not being returned.Therefore, unavailable for a physical evaluation.Since, the complaint device was not returned.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#: (187l873).And no non-conformances 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.H4: device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 7/2/2021.

• 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; raymham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18229459
• MDR Text Key: 329267050
• Report Number: 1221934-2023-04313
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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: 187L873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1