MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX ASSEMBLY - CURVED; STAPLE, FIXATION, BONE

Model Number 72201491

Device Problem Break (1069)

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

Event Date 08/13/2018

Event Type  malfunction  

Event Description

It was reported that t1 broke.Pieces were removed and procedure was completed with a back-up device.No significant delay or patient injury reported.

Manufacturer Narrative

One 72201491 ultra fast-fix curved needle delivery system received.The blue split needle cover cannula was not returned.The white depth/penetration limiter was returned.It was trimmed back beyond the inner sheath.The manual actuator lever was fully retracted.It manually performs as expected.T1 was not returned.The suture was cut at t1 location.T2 and suture were returned.T2 has suture tightly cinched and knotted around it.This is not conducive to affective anchoring.The anchor material has been scored.The suture has unusual damages in other locations aside from the anchor positions.The anchors consist of a durable material for the application.It takes a substantial amount of tension to score or break an anchor.No root cause related to the manufacture of the device was confirmed.

• Brand Name: ULTRA FAST-FIX ASSEMBLY - CURVED
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7847096
• MDR Text Key: 119376037
• Report Number: 1219602-2018-01193
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)211107(10)50630088
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50630088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1