MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON FLEX BIOCRYL STRAIGHT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	208956
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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.Device was used for treatment, not diagnosis.H11 additional narrative: h4: the device manufacture date is currently unavailable.Investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes in used condition.No structural anomalies were found.The anchor was not returned.The gray lever was found broken.The broken fragment was not returned.A review of the batch manufacturing records was conducted on finished lot number 300l856: and no related non-conformances were identified.The overall complaint was not confirmed as the observed condition of the gryphon flex biocryl straight would have not contributed to the complained device issue.Based on the investigation findings, the potential cause for the broken gray lever is traced to excessive force that was applied to the gray lever while delivering the anchor, however, this cannot be conclusively determined.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during a labral repair procedure, it was observed that the lever on the gryphon flex biocryl straight device could not be engaged; and that the anchor would pull out when removing the inserter.During in-house engineering evaluation, it was determined that the gray lever was broken.Another like device was used to complete the procedure.There was patient involvement.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.

• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20620563
• Report Number: 1221934-2024-03808
• Device Sequence Number: 15291969
• Product Code: FZX
• UDI-Device Identifier: 10886705032433
• UDI-Public: (01)10886705032433(10)300L856(17)270430
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: 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 Catalogue Number: 208956
• Device Lot Number: 300L856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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