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

Catalog Number 4403

Device Problem Positioning Failure (1158)

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

Event Date 08/03/2020

Event Type  malfunction  

Event Description

It was reported that, during surgery, the medical staff had issues loading the "tendon anchors", they were not grasped by the "tendon inserter".Additionally, the "tendon anchor inserter" seemed to be mangled.The procedure was completed with a backup device and no significant delay or further 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: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the returned device and noted the plastic is deformed and appears to have been melted.The trigger is protruding from the handle.Functional evaluation revealed the trigger is seized and cannot be depressed.The complaint was confirmed.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.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.

• 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: 10439802
• MDR Text Key: 204010831
• Report Number: 3003604053-2020-00083
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Catalogue Number: 4403
• Device Lot Number: 2044100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1