MAUDE Adverse Event Report: ROTATION MEDICAL, INC. ARTHRO BIOINDCTIVE IMPLANT 1 LARGE; MESH, SURGICAL, DEPLOYER

Model Number	2169-3
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the large arthroscopic bio-inductive implant delivery device broke off during implantation and had to be removed manually.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: dhr review cannot be performed as correct lot# is not provided.Complaint history indicates that are no similar complaints received related to the large arthroscopic bio-inductive implant delivery device broke off during implantation and had to be removed manually.The products, used for treatment, were not returned for evaluation and therefore a physical investigation could not be completed.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.

• Brand Name: ARTHRO BIOINDCTIVE IMPLANT 1 LARGE
• Common Device Name: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no., suite 100; plymouth MN
• MDR Report Key: 9583390
• Report Number: 3009351468-2020-00001
• Device Sequence Number: 458074
• Product Code: ORQ
• UDI-Device Identifier: 00854501006012
• UDI-Public: 00854501006012
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: 2169-3
• Device Catalogue Number: 2169-3
• Device Lot Number: A939
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1