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

Catalog Number	210821
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was observed that the gryphon peek w/pokot device came out as the surgeon was knotting and lowering the implant after placement.There was patient involvement.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 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: investigation summary = > the product has not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment (source file - novedad 513189 policlínico del olaya).The photo investigation revealed that gryphon peek w/proknot had the anchor broken at the distal end, the anchor was detached form the inserter.No other anomalies could be observed.A review of the batch manufacturing records was conducted on finished lot number xxxxxx: and no related non-conformances were identified.The overall complaint was confirmed as the observed condition of the gryphon peek w/proknot would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause for the reported condition could be traced to the anchor breakage.The broken condition 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 or inserter fracture, and 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 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.------------------------------------- document specification review: ifu-111331 device history lot = > pn: 210821 lot number: 8l94908 there was no non-conformance regarding this lot.Manufacturing date: 17 feb 2022 expiration date: 31 jan 2025 device history batch = > null.Device history review = > n: 210821 lot number: 8l94908 there was no non-conformance regarding this lot.Manufacturing date: 17 feb 2022 expiration date: 31 jan 2025.
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 has been updated to reflect the correct information: the investigation summary the product has not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that gryphon peek w/proknot had the anchor broken at the distal end, the anchor was detached form the inserter.No other anomalies could be observed.A review of the batch manufacturing records was conducted on finished lot number xxxxxx: and no related non-conformances were identified.The overall complaint was confirmed as the observed condition of the gryphon peek w/proknot would contribute to the complained device issue.¿ based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause for the reported condition could be traced to the anchor breakage.The broken condition 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 or inserter fracture, and 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 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.

• Brand Name: GRYPHON PEEK W/PROKNOT
• 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: 20527072
• Report Number: 1221934-2024-03812
• Device Sequence Number: 20862840
• Product Code: MAI
• UDI-Device Identifier: 10886705024049
• UDI-Public: (01)10886705024049(10)8L94908(17)250131
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K140643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 01/31/2025
• Device Catalogue Number: 210821
• Device Lot Number: 8L94908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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