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

Model Number	2169-2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a surgery in which a regeneten bioinductive implant was used over a repair made to treat a musculotendinous junction tear of the infraspinatus, the patient had objective stiffness early in the post operative course, starting at 6 weeks and which persisted throughout the post operative period.No signs of systemic infection.Imaging 8 9 months out showed subacromial bursistis and a tear in line with tendon fibers.The patient was taken to the or where the subacromial bursa was aspirated, biopsied (with frozen section) and cultured.The subacromial bursa was dense with significant scarring directly over the implant as well as laterally.A washout was performed with vancomycin.The bioinductive implant had integrated into tendon laterally but had lifted medially, which he repaired with suture and performed a side to side repair of the tendon.There was synovitis in the glenohumeral joint, which was largely affected; this was treated intraoperatively with an intra articular steroid injection.The patient was diagnosed with septic bursitis and treated for 6 weeks with vancomycin.Now, several months later, patient has progressed well and has returned to playing cello, though he is reportedly not fully improved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: lot number information is not provided and no additional information received for documentation review.Another complaint related to infection post procedure with scaffold has been observed.The risks associated with complaint are already included in the risk analysis.Also the probability is appropriate.Device labeling was reviewed.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.Root cause was undetermined after investigation.Failure mode experienced by the user facility were unable to be confirmed through direct physical investigation.No clinical/medical documentation was provided for the investigation.Without supporting clinical/medical documents a thorough investigation cannot be performed.

• Brand Name: ARTHRO BIOINDCTIVE 1 MED
• Common Device Name: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no., suite 100; plymouth MN
• MDR Report Key: 9302917
• Report Number: 3009351468-2019-00117
• Device Sequence Number: 2363149
• Product Code: OWY
• UDI-Device Identifier: 00854501006005
• UDI-Public: 00854501006005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2169-2
• Device Catalogue Number: 2169-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR