MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL GRYPHON FLEX BIOCRYL STRAIGHT; UNK - IMPLANT

Catalog Number	208956
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
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 mitek or its employees that the report constitutes an admission that the device, 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: d10: concomitant med products and therapy dates: unk - implant device, on (b)(6) 2024 d1, d4, g1, g4 (510k), h4: this report is for an unknown implant.Part and lot number are unknown.Without the specific part number, the expiration date, udi number, 510-k number, manufacturing site name, and device manufacture date are unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
This is report 1 of 2 for (b)(4) it was reported that during a hip arthroscopy procedure, it was discovered that two unknown anchor devices had straight button on top of the anchor that was not engaged properly.It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2024.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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 mitek or its employees that the report constitutes an admission that the device, 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: b3, b5: during subsequent follow-up with the customer additional information was obtained.The reporter clarified that the event occurred on 07 jun 2024.It was further reported that the strike cap was bent, and the lever was extremely difficult to deploy.The device was gryphon flex biocryl straight.H6.Medical device problem code: the codes have been updated based on the additional information provided by the customer.D1, d2a, d4, g4 (510k), udi: the device part / product code and lot number has been identified and updated accordingly.Udi (b)(4).
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 mitek or its employees that the report constitutes an admission that the device, 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: d4, h4: the device manufacture date and expiration date were unavailable in the initial medwatch report.Therefore, the udi was incomplete.The device manufacture date and expiration date has been identified and updated accordingly.Investigation summary: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (305l477), and no non-conformance was identified.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.

• Brand Name: GRYPHON FLEX BIOCRYL STRAIGHT
• Common Device Name: UNK - IMPLANT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19567589
• Report Number: 1221934-2024-02108
• Device Sequence Number: 15197151
• Product Code: MAI
• UDI-Device Identifier: 10886705032433
• UDI-Public: 10886705032433
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup,Followup
• Report Date (Section B): 06/19/2024

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: 305L477
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 07/30/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/21/2024; 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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