MAUDE Adverse Event Report: ROTATION MEDICAL, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2503-A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the distal part of the inserter came off after deploying the patch.It came off after the patch was tacked down while attempting to remove inserter from the patient's shoulder.A backup device was available to complete the procedure with no patient injuries but there was a delay greater than 30 minutes.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: review of the applicable device history review did not indicate any nonconformance¿s, 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 the distal part of the inserter came off after deploying patch.The products, used for treatment, were returned for evaluation.Investigated the returned devices.A total of one delivery system was returned and the exterior condition of this returned device shows no damage.In order to provide a complete assessment of the product, it would be required to examine the cartridge head which was not returned with the product.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: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ROTATION MEDICAL, INC.; 15350 25th ave. no., suite 100; plymouth MN
• MDR Report Key: 9520578
• Report Number: 3009351468-2019-00120
• Device Sequence Number: 595485
• Product Code: LXH
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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: 2503-A
• Device Catalogue Number: 2503-A
• Device Lot Number: A7019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 12/26/2019
• 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