MAUDE Adverse Event Report: DePuy Mitek LLC US GRYPHON Flex; Fastener, fixation, nondegradable, soft tissue

Catalog Number	208955
Medical Device Problem Codes	Product Quality Problem (1506); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a right shoulder bankart repair shoulder procedure, it was observed that the threader tab of the gryphon flex peek straight device was missing from the implant.It was reported that a threader tab from a previous implant was used to load the suture onto the implant.During visual inspection of a photo that was received found the inserter outside of the packing without the kite assembled.It was reported that there was no delay in the procedure due to the event.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11.Additional narrative: investigation summary: a photo of the product was provided to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the photo found the inserter outside of the packing without the kite assembled.No other anomalies were noted.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to unestablished cause.The presented evidence alone cannot definitively distinguish between packing omissions or site removal, therefore a potential cause for the reported condition could not be established.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.

• Brand Name: GRYPHON Flex
• Common Device Name: Fastener, fixation, nondegradable, soft tissue
• Manufacturer (Section D): DePuy Mitek LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50896172
• Report Number: 1221934-2026-04346
• Device Sequence Number: 5828849
• Product Code: MBI
• UDI-Device Identifier: 10886705032488
• UDI-Public: (01)10886705032488(10)10GX55(17)290531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K232492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• 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 Catalogue Number: 208955
• Device Lot Number: 10GX55
• 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: 09/23/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2026
• 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