MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON P BR DS ANCHOR W/ORTHOCORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 210813

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

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.Udi: (b(4) incomplete.The expiration date is currently unavailable.The device manufacture date is currently unavailable.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 sent.

Event Description

It was reported by a healthcare professional in china that during an arthroscopic shoulder stabilization procedure on (b)(6) 2023, it was observed that the suture on the gryphon p br ds anchor w/orthocord device was looser than normal upon opening its package; and therefore, was not used.According to the report, the anchor on the device broke off during use.Removed all the broken parts.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.

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.H10 additional narrative: investigation summary the complaint device was received and evaluated.On visual inspection, the device comes in used condition.The sutures are already removed from the shaft; therefore, it is not possible to verify the loose condition.The shaft and inserter tip are in good condition, no structural anomalies were found.The anchor is broken in half.A manufacturing record evaluation was performed for the finished device 132l686 number, and no non-conformances related to the reported complaint condition were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, the reported complaint can be confirmed only for the broken condition of the anchor.The loose condition of the suture cannot be confirmed since the suture was removed from the shaft.A possible root cause for the broken condition can be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment may was applied.As per ifu: axial misalignment or levering with the anchor upon insertion, may result in anchor or inserter fracture.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GRYPHON P BR DS ANCHOR W/ORTHOCORD
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17301921
• MDR Text Key: 318898117
• Report Number: 1221934-2023-02689
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001279
• UDI-Public: 10886705001279
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Model Number: 210813
• Device Catalogue Number: 210813
• Device Lot Number: 132L686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/26/2023; 07/30/2023
• Supplement Dates FDA Received: 07/27/2023; 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1