MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON¿ BR DS ANCHOR WITH PERMACORD¿ SIZE 2, 36"; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	223147
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
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, a follow-up will be filed as appropriate.Udi: (b)(4).Reporter is a j&j sales representative.The device manufacture date is currently unavailable.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 distal part was bent, and the anchor was not in the inserter.Based on the condition, this complaint reported was not confirmed.A manufacturing record evaluation was performed for the finished device 9l11253, 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 off -axis insertion, levering during insertion or excess tension applied on anchor which caused damage near the inserter.The possible root cause can be related with the damage in the anchor which could¿ve caused the anchor to fall off the inserter.However, it cannot be conclusively affirmed.As per ifu, apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture, axial misalignment or levering with the anchor upon insertion, may result in anchor or inserter fracture.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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.
Event or Problem Description
It was reported by sales rep that during a distal biceps repair procedure on (b)(6) 2022, it was observed that the handle dislodged from the shaft when attempting to remove the inserter on the gryphon¿ br ds anchor with permacord¿ size 2, 36" device after anchor was implanted.According to the report, the anchor remained strongly fastened in the bone with no issues with the sutures.They used a kocker and a mallet to dislodge the shaft from the anchor after insertion.During in-house engineering evaluation of the photo provided by the customer, it was determined that the distal part on the device was bent, and the anchor was not in the inserter.There were no surgical delay nor adverse patient consequences reported.No additional information was provided.

• Brand Name: GRYPHON¿ BR DS ANCHOR WITH PERMACORD¿ SIZE 2, 36"
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• 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: 16227582
• Report Number: 1221934-2023-00431
• Device Sequence Number: 20183581
• Product Code: MAI
• UDI-Device Identifier: 10886705024612
• UDI-Public: 10886705024612
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 04/30/2025
• Device Model Number: 223147
• Device Catalogue Number: 223147
• Device Lot Number: 9L11253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/23/2023
• 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