MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON P BR W PERMACORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 223146

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown; therefore, the expiration date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

This file is a review of the following journal article: deasey, m.J., et al (2020) small, short, oblique patellar tunnels for patellar fixation do not increase fracture risk or complications in mpfl reconstruction a retrospective cohort study.The orthopaedic journal of sports medicine, vol.8, pages 1-7 (usa).The study emphasizes on the evaluation of the risk of patellar fracture and other outcomes associated with smaller (3.2-mm), short, oblique patellar tunnels as compared with suture anchor fixation in mpfl reconstruction.The patients evaluated on course of this study: a total of 384 knees in 352 patients undergoing primary mpfl reconstruction were identified.The article describes the following procedure: mpfl reconstruction surgery.The devices involved were: gryphon anchor.Complications described: of those patients treated with a gryphon anchor, 3 required revision surgery and 9 had subsequent joint instability.

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.Investigation summary: the complaint device is not being returned; the availability of the device is unknown, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: GRYPHON P BR W PERMACORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11293929
• MDR Text Key: 231975892
• Report Number: 1221934-2021-00417
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705024629
• UDI-Public: 10886705024629
• Combination Product (y/n): N
• PMA/PMN Number: K141259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 223146
• Device Catalogue Number: 223146
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention