MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON BR W/ PROKNOT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	210820
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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: the complaint device was implanted in the patient, therefore not returned to j&j medtech orthopaedics and unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (218l945), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If 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 and/or preventative action is proposed and 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.
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.H10 additional narrative: to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported by the sales rep in france that following a "butée latarjet" procedure on (b)(6) 2024, a gryphon br w/ proknot device was used to reconstruct the capsule.According to the reporter, the first anchor broke at the top of the screw thread.There was patient involvement.It was reported that fragments were generated.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.
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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the implant was still attached to the inserter.The anchor was slightly deformed at the distal end.Neither the inserter nor the suture had any anomaly that could be observed.The overall complaint was not confirmed as the observed condition of the gryphon p br ds anchor w/oc would have not contributed to the complained device issue.Based on the investigation findings, the potential cause for the device condition is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause can be associated with off axis insertion and levering during insertion.As per ifu, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.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 complaint condition.As part of depuy synthes 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.Device history lot: a manufacturing record evaluation was performed for the finished device, and no non-conformance was identified.
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: the two new products were returned to depuy synthes for evaluation.Visual inspection of the returned devices found that the implants were returned completely sealed in the packaging.The anchor was slightly deformed at the distal end for both devices.Neither the inserter nor the suture had any anomaly that could be observed.The manufacturer performed an investigation of the device with the following results: as per the images presented, anchor seems to be misaligned but there was no evidence of the anchor having any damage that could cause breakage.The suture appeared to have lost the tension across the shaft as it looked loose and outside of the shaft.In accordance with the manufacturing procedure, the anchor is placed on the device by lulling the suture and resting the anchor on the tip of the shaft.Inspection of this attribute is 100% inspected by the manufacturing associate.The suture must be in place, aligned and the anchor must properly seat in the shaft.The investigation performed showed that the production controls implemented at the non-sterile level, as well as the in-process controls guarantee detection of issues related to the positioning of the anchor.100% of the product undergoes manufacturing controls for this kind of defect, and additionally every batch passes through quality inspection.The misalignment of the anchor was found in the unused product that was received but the defect related to breakage was not seen and there was no evidence that suggests that this issue could have happened in this new product.Based on the information presented under this investigation, it is confirmed that manufacturing process has stablished validated procedures which are designated to prevent and detect this defect.The overall complaint was not confirmed as the observed condition of the gryphon p br ds anchor w/oc would have not contribute to the complained device issue.Based on the investigation findings, the potential cause for the device condition could not be established.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 complaint condition.As part of depuy synthes 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.

• Brand Name: GRYPHON BR W/ PROKNOT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 20506610
• Report Number: 1221934-2024-03720
• Device Sequence Number: 12857237
• Product Code: MBI
• UDI-Device Identifier: 10886705024025
• UDI-Public: (01)10886705024025(10)218L945(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 210820
• Device Lot Number: 218L945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/28/2024; 12/06/2024; 01/13/2026; 01/13/2026
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 10/29/2024; 12/09/2024; 01/15/2026; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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