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

Catalog Number 210813

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 03/27/2024

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.Device was used for treatment, not diagnosis.H10 additional narrative: (b)(4) h4: the device manufacture date is currently unavailable.Investigation summary the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4) (1) and (b)(4) (2)).The photo investigation revealed that the device in used condition.The anchor is cracked on the distal part.The cracked part shows a brownish color which is indicative of use.The overall complaint was unconfirmed as the observed condition of the gryphon p br ds anchor w/oc would not contribute to the complained device issue.A manufacturing record evaluation was performed; and no related non-conformances were identified.Based on the investigation findings, a potential root cause can be attributed to a procedural variables, such handling of the device or product interaction during procedure; axial misalignment may occurred.As per ifu: axial misalignment or levering with the anchor upon insertion, may result in anchor or inserter 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.

Event Description

It was reported from china that during an unspecified surgical procedure, it was observed that the anchor on the gryphon p br ds anchor w/oc device was broken upon opening its package.During in-house engineering evaluation, it was determined that the anchor was cracked on the distal part.There were no delays in the surgical procedure as an identical spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.H4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.

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: d9, h3, h6: 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.

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: investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found that the device comes in used condition.The anchor is cracked on the distal part.The cracked part shows biological matter which is indicative of use.The overall complaint was confirmed as the observed condition of the gryphon p br ds anchor w/oc would contribute to the complained device issue.Based on the investigation findings, a potential root cause can be attributed to a procedural variables, such handling of the device or product interaction during procedure; axial misalignment may occurred.As per ifu: axial misalignment or levering with the anchor upon insertion, may result in anchor or inserter 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 review a review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: GRYPHON P BR DS ANCHOR W/OC
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• 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: 19087346
• MDR Text Key: 340125954
• Report Number: 1221934-2024-01174
• 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,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 Catalogue Number: 210813
• Device Lot Number: 220L148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/22/2024; 04/23/2024; 04/30/2024
• Supplement Dates FDA Received: 04/23/2024; 04/24/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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