MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYS ADVNCD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72205205

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 10/15/2020

Event Type  Injury  

Event Description

It was reported that, during arthroscopic surgery, the surgical staff only was able to get one (1) staple to remain intact when they did not fully depress the handle to the point of hearing the "click" while loading the anchor.In other words, when they heard a "click" from the handle upon loading, and another "click" when implanting, the tendon anchor continuously failed at the bridge breaking into two (2) separate pieces.However, if no "click" was heard when loading the tendon anchor from the puck, but if a "click" was heard only when implanting, then the tendon anchor did not fail nor break.The procedure was successfully completed without significant delay using the same faulty device since even broken, the anchors sufficiently held the implant in place.No additional complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that, during a rotator cuff (supraspinatus tendon) repair surgery, the surgical staff only was able to get one (1) staple to remain intact when they did not fully depress the handle to the point of hearing the "click" while loading the anchor.In other words, when they heard a "click" from the handle upon loading, and another "click" when implanting, the tendon anchor continuously failed at the bridge breaking into two (2) separate pieces.However, if no "click" was heard when loading the tendon anchor from the puck, but if a "click" was heard only when implanting, then the tendon anchor did not fail nor break.The procedure was successfully completed without significant delay using the same faulty device since even broken, the anchors sufficiently held the implant in place.No additional complications were reported.

Manufacturer Narrative

Complaint internal reference (b)(4).H10, h2, h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found excessive force applied during anchor deployment may result in damage to the tissue, to the material being fixated, or to the anchor.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYS ADVNCD
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10813276
• MDR Text Key: 215579034
• Report Number: 3003604053-2020-00145
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556733547
• UDI-Public: 885556733547
• Combination Product (y/n): N
• PMA/PMN Number: K131635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2023
• Device Catalogue Number: 72205205
• Device Lot Number: 2048691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1