MAUDE Adverse Event Report: ROTATION MEDICAL, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 4566

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff repair the patch was smaller than the large size listed on the box.The procedure was completed with the same device with no delay or patient injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h6: review of the applicable dhrs did not indicate any nonconformance, deviations or other issues with devices involved in this issue.A complete review of manufacturing documentation was conducted and the devices were found to be within specification.Complaint history indicates that are no similar complaints received related to patch (scaffold) was smaller than the large size listed on box.This is the first (and only) complaint related to patch (scaffold) was smaller than the large size listed on box.The products, used for treatment, were not returned for evaluation and therefore a physical investigation could not be completed.Root cause was undetermined after investigation.Failure mode experienced by the user facility were unable to be confirmed through direct physical investigation.No further investigation warranted at this time.Although the issues experienced by the user facility were unable to be confirmed through direct physical investigation, the issue will be monitored for trending purposes.

• Brand Name: BIOINDUCTIVE IMPLANT W/ARTH DEL LRG
• Type of Device: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no., suite 100; plymouth MN
• MDR Report Key: 9656964
• MDR Text Key: 195537409
• Report Number: 3009351468-2020-00004
• Device Sequence Number: 1
• Product Code: OWY
• Combination Product (y/n): N
• PMA/PMN Number: K140300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Catalogue Number: 4566
• Device Lot Number: A7362
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1