MAUDE Adverse Event Report: ROTATION MEDICAL, INC. ARTHRO BIOINDUCTIVE IMPLANT; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that after a case the doctor ordered an mri and it showed a foreign body in the lateral bursa in the upper arm, the surgeon believes it is the graft.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: lot number information 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.The risks associated with complaint are already included in the risk analysis.Also the probability is appropriate.Instructions for use and product labels were not reviewed due to unavailability of device information (part number, lot number).Complaint history indicates that are no similar complaints received related to implant movement / migration.Imaging, operative reports, and/or explants were not provided for inclusion in a medical investigation, therefore a thorough medical assessment could not be performed and the root cause could not be concluded.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.The products, 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.With given information we determine that foreign body has not been identified.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: ARTHRO BIOINDUCTIVE IMPLANT
• 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: 9634353
• MDR Text Key: 200794984
• Report Number: 3009351468-2020-00003
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1