MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GRYPHON; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK GRYPHON

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

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.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.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: maj brian r.Waterman, et al, 2015 ¿slap repairs with combined procedures have lower failure rate than isolated repairs in a military population¿, the orthopaedic journal of sports medicine, 3(8) (usa) the purpose of the study was to quantify the rate of clinical failure and surgical revision after isolated and combined slap repair.A total of 192 patients with slap repair were identified with a mean follow-up of 50.0 months (sd, 17.0 months).Isolated slap repair occurred in 31.3% (n = 60) versus 68.8% (n = 132) with concomitant procedures.All consecutive active-duty service members undergoing arthroscopic repair of type ii slap lesions at a single institution between 2006 and 2012 were identified.Patients with less than 2-year clinical follow-up and nonmilitary status were excluded.Demographic variables, surgical variables, and occupational outcomes were extracted from electronic medical records and confirmed with the us army physical disability agency database.Failure was defined as subsequent revision surgery or medical discharge with persistent shoulder complaints.Patients with arthroscopic confirmation of a slap lesion underwent subsequent biocomposite 3-mm suture anchor repair (suturetak; arthrex, or gryphon; depuy mitek), with or without additional arthroscopic treatment of concomitant shoulder pathology and were included for further analysis.The device involved: gryphon (depuy mitek).Complications mentioned in the study: at final follow-up, 37.0% (n = 71) of patients reported some subjective activity-related shoulder pain.Postoperative return to duty occurred in 79.6% (n = 153) of patients, and only 20.3% (n = 39) were discharged with continuing shoulder disability, indicating clinical failure.Thirty-one (16.1%) patients were classified as surgical failure and required revision.Of these, the majority of patients undergoing biceps tenodesis (76%) returned to active duty, as compared with revision slap repair (17%).Lower demand occupation and the presence of combined shoulder injuries (p =.011 and.016, respectively) were significantly associated with a lower risk of medical discharge and revision surgery, respectively.Favorable outcomes can be anticipated in the majority of military service members after arthroscopic slap repair, particularly with combined shoulder injuries.Revision surgery occurred in 16% of patients after primary slap repair.Isolated repair of unstable slap lesions and/or increased upper extremity demands are associated with higher failure rates in this population.

• Brand Name: UNKNOWN GRYPHON
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9245319
• MDR Text Key: 178668127
• Report Number: 1221934-2019-59273
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK GRYPHON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention