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

Catalog Number UNK - IMPLANT

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

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: weihui qi and yanyun ren (2023), bone abscess formation around suture anchors after double-row fixation in arthroscopic rotator cuff repair, vol.93, no.Na, pages 2524¿2526 (china).This is a complaint.After initial shoulder rotator cuff repair the patient presented with pain and after mri it was determined a cyst existed around the humeral anchor.Re-operation was performed and chronic deep infection was identified (staphylococcus pasteuri - from later pathology results).Clean-out was performed.Shoulder repair was all still intact.After lengthy oral antibiotic regimen, patient fully recovered.A copy of this literature article is attached to this medwatch report.

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: d1, d4, g1, g4 (510k), h4: this report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the expiration date, udi number, 510-k number, manufacturing site name, and device manufacture date are unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.

• Brand Name: UNK - IMPLANT
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• 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: 18354414
• MDR Text Key: 330870292
• Report Number: 1221934-2023-04630
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female