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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the tendon stapler had a failure, out of all 4 staplers and 3 pucks on tendon anchors, 2 successfully grabbed and 1 successfully implanted.A back up device was available and a delay greater that 30 minutes was reported.No patient injury was 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: review of the applicable dhrs did not indicate any nonconformance, 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.Several loading related complaints have been observed and are related to tendon stapler stakes that are too small to engage tendon staples.The products, used for treatment, were returned for evaluation.Investigated the returned devices.A total of four tendon staplers were returned and appeared undamaged.Following visual inspection, the complaint was verified by attempting to load the anchors.No anchors were able to be loaded with the accompanying tendon anchor inserters.Various inspection methods have shown that the stakes are undersized and are leading to loading difficulties.Root cause was determined after investigation.Failure mode experienced by the user facility was confirmed through direct physical investigation, similar complaints have been reported with these devices from other users.

• 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: 9216647
• Report Number: 3009351468-2019-00114
• Device Sequence Number: 2233619
• Product Code: LXH
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/25/2020

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: 03/09/2020
• Device Model Number: 2503-A
• Device Catalogue Number: 2503-A
• Device Lot Number: A7148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1