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

Catalog Number	2503-A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Inflammation (1932); Blood Loss (2597)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a rotator cuff repair surgery, the tendon anchors were unable to be loaded from the container onto the staplers.When a stapler was introduced to one of the holes of the container and the stapler trigger was squeezed, the inner pins of the stapler went around the tendon anchor like normal, but was unable to grasp it.The inner pins slid off the tendon anchor without removing the anchor from its position within the container.This was attempted on each staple in the container with both staplers, but only 3 of them were able to be loaded.To solve the issue, additional tendon anchors and tendon staplers were opened.All staplers that were opened were used.Eventually, between the two sets, 6 staples were retrieved and used.The surgery was delayed for 8-10 min.The patient was stated to be harmed because of the blood loss due to the extended surgical time; the swelling increased due to additional saline having to be pumped into the shoulder, which can cause additional pain.Additional stretching of muscle surrounding subacromial space was required to see properly due to swelling and additional tissue resection was required to see properly due to swelling.The patient outcome is unknown.
Additional Manufacturer Narrative
The product was not returned for evaluation and therefore a physical investigation could not be completed.A complete review of manufacturing documentation was conducted and the device was found to be within specification.Although the issues experienced by the user facility were unable to be 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 55447
• MDR Report Key: 9076584
• Report Number: 3009351468-2019-00106
• Device Sequence Number: 14047650
• Product Code: LXH
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2020
• Device Catalogue Number: 2503-A
• Device Lot Number: A7121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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