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 Break (1069); Device Damaged Prior to Use (2284); Contamination /Decontamination Problem (2895)

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

Event Date 01/26/2024

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 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.(b)(4) investigation summary: the product has not returned to depuy synthes mitek, however a photo was provided for review.The photo investigation revealed that gryphon p br ds anchor w/oc had the implant broken at the proximal end.The anchor has foreign matter, presumably biological matter on the broken section.No other anomalies could be observed.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, the potential cause for the device condition is traced to the procedural variables, such handling of the device or product interaction during procedure, as the device show signs of use, the reported complaint of failure without use cannot be confirmed 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 depuy synthes mitek 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: there were no non conformance regarding this lot.

Event Description

It was reported by the sales rep that during an unspecified surgical procedure, the gryphon p br ds anchor w/oc device opened the packing(did not use), noted the anchor was broken off.During in-house engineering evaluation, it was determined that the device was broken at the proximal end and had foreign matter.There were no adverse patient consequences 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 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.Device was used for treatment, not diagnosis.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 product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.Visual inspection found that gryphon p br ds anchor w/oc had the implant broken at the proximal end.The anchor and the handle have foreign matter, presumably biological matter.No other anomalies could be observed.The photo investigation revealed that gryphon p br ds anchor w/oc had the implant broken at the proximal end.The anchor has foreign matter, presumably biological matter on the broken section.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the 4 gryphon p br ds anchor w/oc would contribute 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 the instructions for use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.As the device show signs of use, the reported complaint of failure without use cannot be confirmed 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 depuy synthes mitek 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: there was no non conformance regarding this lot.

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.Device was used for treatment, not diagnosis.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 the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• 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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18705177
• MDR Text Key: 335442112
• Report Number: 1221934-2024-00476
• Device Sequence Number: 1
• Product Code: MAI
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 233L068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1