MAUDE Adverse Event Report: ROTATION MEDICAL, INC. ARTHRO BIOINDCTIVE 1 MED; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number 2169-2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 05/26/2019

Event Type  Injury  

Event Description

Subject id: (b)(6).Ae description: left shoulder pain.Ae#: (b)(6).It was reported that after arthroscopy surgery with bioinductive implant, patient had pain in the left shoulder.The event was treated with revision surgery.The outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: dhr review cannot be performed as correct lot# is not provided and no additional information received for documentation review.If additional information is received, the documentation review will be revisited.With given information cannot able to determine if device met manufacturing specifications.Several complaints related to post procedure with scaffold has been observed.The risks associated with complaint are already included in the risk analysis.Reference risk management file 16000188.All instructions for use and product labels were found to be current, complete and comprehensive.The product used for treatment, was not returned for evaluation and therefore a physical investigation could not be completed.Limited information provided was insufficient to base an assessment of the root cause and patient impact beyond the reported events.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.Insufficient information to determine root cause.Probable cause of the failure mode experienced by the user facility were unable to be confirmed through direct physical investigation.Investigation will be revisited if additional information is received.

• Brand Name: ARTHRO BIOINDCTIVE 1 MED
• 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: 10151410
• MDR Text Key: 195106360
• Report Number: 3009351468-2020-00005
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2169-2
• Device Lot Number: RC2AN1967
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/28/2020
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention