MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS, 3, W/ARTHRO DEL SYS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number BONE ANCHORS 3 W ARTHRO DEL SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair, the tendon stapler did not work properly.It was stated that the tendon stapler used out malfunctioned when trying to retrieve the tendon staples from the device.This caused the tendon staples to no longer be usable and the surgeon decided not to use the product.This did not slow down the case.The procedure was completed without delay using a smith & nephew 5.5 footprint ultra pk knotless anchors.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.

Manufacturer Narrative

H10.H3, h6: "review of the applicable dhrs did not indicate any non conformances, deviations or other issues with devices involved in this issue.Several loading related complaints have been observed and are related to tendon stapler stakes that are too small to engage tendon staples.The risks associated with the complaint are already included in the risk analysis.Device labeling was reviewed.All instructions for use and product labels were found to be current, complete and comprehensive.The products, used for treatment, was 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.Root cause was determined after investigation.Failure mode 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.Per customer response, ¿the surgeon stated that the patient is doing well with no complications¿.Based on this information, no patient impact resulted and further medical assessment is not warranted at this time.".

• Brand Name: BONE ANCHORS, 3, W/ARTHRO DEL SYS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10027028
• MDR Text Key: 189974734
• Report Number: 3003604053-2020-00034
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Device Lot Number: 50797812
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/14/2020
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 07/11/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other