MAUDE Adverse Event Report: ROTATION MEDICAL, INC. BIOINDUCTIVE IMPLANT WITH ARTHROSCOPIC DELIVERY SYSTEM - MEDIUM; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Model Number 4565

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 05/26/2021

Event Type  malfunction  

Event Description

Patient has known left partial rotator cuff tearing and a superior labrum anterior posterior tear which has failed to respond to conservative management.The patient underwent left (l) shoulder arthroscopic rotator cuff repair using a regeneten bioinductive implant, l shoulder arthroscopic subacromial decompression, and l shoulder arthroscopic extensive debridement.During 5 week follow-up appointment, patient complained of severe and significant pain localized over the anterior aspect of her shoulder for the last 2 weeks.Patient reported a feeling of "something metal stuck in her shoulder".She had an mri without contrast done, which showed moderate subacromial-subdeltoid bursitis noted diffusely although also present near the screw tracks in the previous surgery.Low-grade, partial-width, bursal-sided supraspinatus tendon fraying.Labs showed no indication for infection.Betamethasone injection given, but patient reports pain increasing after injection.Patient returned to the or where it was found there was evidence of midsubstance rupture of the regeneten bioinductive implant patch with tissue flipped on itself in the lateral gutter.Surgeon debrided the patch out and removed all staples.No growth found on biopsied tissue.

• Brand Name: BIOINDUCTIVE IMPLANT WITH ARTHROSCOPIC DELIVERY SYSTEM - MEDIUM
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no.; suite 100; plymouth MN 55447
• MDR Report Key: 12016057
• MDR Text Key: 256704449
• Report Number: 12016057
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4565
• Device Catalogue Number: 4565
• Device Lot Number: A8686
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA
• Patient Weight: 67