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

Model Number 2503-A

Device Problem Failure to Align (2522)

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 rotator cuff repair surgery the tendon anchors were not being grasped by tendon inserter (bone anchors 3 w arthro del system).The correct technique was being used, but the tendon inserter appeared to be mangled.The procedure was completed without delay using a s+n backup device.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

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already reported under mdr no.3003604053-2020-00087, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10446219
• MDR Text Key: 204199558
• Report Number: 3003604053-2020-00086
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2503-A
• Device Catalogue Number: 2503-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1