MAUDE Adverse Event Report: DEPUY MITEK LLC US 60° SUTURE GRASPER; SUTURE/NEEDLE PASSER, REUSABLE

Model Number	251723
Medical Device Problem Codes	Material Deformation (2976); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
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 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.Additional narrative: udi: (b)(4).Reporter is a j&j employee.Investigation summary = > the complaint device was received and evaluated.Upon visual inspection, the device was found to be in good structural shape, the shaft has no damage as well as the needle, the wire hook shape is deformed.The hook can be retracted inside the shaft by pushing the button.A manufacturing record evaluation was performed for the finished device 8l67350 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and functional test result, this complaint cannot be confirmed.The customer reported that the hook was already out of the needle when unsealing the blister, however there is no evidence that the hook was already out of the needle, no photos were provided by the customer.The root cause for the abnormal hook shape can be attributed to the fact that the device was returned without its blister, therefore the wire got deformed.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the affiliate in japan that during an arthroscopic rotator cuff repair procedure on (b)(6) 2022, it was observed that the 60° suture grasper was unsealed that the hook on the needle had already come out.According to the report, they tried to retract the hook back into the needle but failed.During in-house engineering evaluation, it was determined that the wire hook shape on the device was deformed.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.The device was brand new and the first use when the issue occurred.No additional information was provided.

• Brand Name: 60° SUTURE GRASPER
• Common Device Name: 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: 14697181
• Report Number: 1221934-2022-01758
• Device Sequence Number: 12093947
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Expiration Date: 09/30/2026
• Device Model Number: 251723
• Device Catalogue Number: 251723
• Device Lot Number: 8L67350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown