MAUDE Adverse Event Report: DePuy Mitek LLC US GRYPHON FLEX BIOCRYL STRAIGHT; Fastener, fixation, biodegradable, soft tissue

Catalog Number	208956
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 1 of 2 of (b)(4).It was reported that during a labral repair procedure surgery, the gryphon flex biocryl straight device lever was not releasing.It was stuck and if the user tried to really push it, it would have broken.The user malleted the anchors back out which was not ideal.A spare device was used to complete the procedure.There was no delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization. all available information has been disclosed.
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: since the complaint device was discarded, we cannot determine a root cause for the reported failure.If the device or additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.There was a non-conformance related to this event.

• Brand Name: GRYPHON FLEX BIOCRYL STRAIGHT
• Common Device Name: Fastener, fixation, biodegradable, 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: 50934023
• Report Number: 1221934-2026-04442
• Device Sequence Number: 10739643
• Product Code: MAI
• UDI-Device Identifier: 10886705028825
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K232492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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: 208956
• Device Lot Number: 290L929
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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