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 Codes	Unintended Ejection (1234); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tendon anchor could not be initially loading onto the tendon stapler.The procedure was successfully completed with a significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H6: the products were not returned for evaluation and therefore a physical investigation could not be completed.A complete review of manufacturing documentation was conducted and the devices were 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: 8974318
• Report Number: 3009351468-2019-00105
• Device Sequence Number: 235371
• 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): 09/17/2019

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 Catalogue Number: 2503-A
• Device Lot Number: A7120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1