MAUDE Adverse Event Report: ROTATION MEDICAL, INC.; MESH, SURGICAL, COLLAGEN

Catalog Number 2169-2

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

Patient underwent arthroscopic repair of glutea tendon with a regeneten patch (bioinductive collagen implant).Patch successfully placed, anchored, and deployment instrument removed.Surgical procedure completed and patient discharged to home the same day.Patient returned for two week follow up with orthopedist at which time imaging was completed and showed a retained foreign body suspected to be in subcutaneous tissue or it band.The patient was returned to the or and the foreign body location was confirmed with fluoroscopy and retrieved.Foreign body identified to be in the subcutaneous tissue between the it band and the skin.The removed foreign body was identified as the spring mechanism of the delivery system for the regenten patch and a small plastic piece attached to it.Fluoroscopy confirmed no further retained foreign body.The patient was discharged to home on the same day.The manufacturer was notified of the event by materials management.

• Type of Device: MESH, SURGICAL, COLLAGEN
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th avenue; suite 100; plymouth MN 55447
• MDR Report Key: 8443182
• MDR Text Key: 139554185
• Report Number: 8443182
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2169-2
• Device Lot Number: RC2AN18K4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA
• Patient Weight: 64