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

Catalog Number	251723
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
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.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 or Problem 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.
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.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.

• 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; raymham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18229459
• Report Number: 1221934-2023-04313
• Device Sequence Number: 5673947
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 251723
• Device Lot Number: 187L873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown