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

Model Number 72201491

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/06/2018

Event Type  malfunction  

Event Description

It was reported that during the surgery, after t1 was stripped off successfully, t2 failed to be stripped off by manual advancement.A backup device was used to complete the surgery.No patient injury was reported.

Manufacturer Narrative

One 72201491 ultra-fast-fix needle delivery system device received.The complaint said: ¿it was reported that during the surgery, after t1 was stripped off successfully, t2 failed to be stripped off by manual advancement.¿ the blue split cannula was returned separated from the delivery needle.The white depth/penetration limiter was returned and has been trimmed.T1 is missing.T2 and partial suture are separated from the needle.The device is severely disfigured.The actuator¿s manual advancement button was received fully forward.The device is beyond mechanical testing due to manipulation and damages attained.Twist or bend can interfere with advancement and removal of t¿s.No root cause related to the manufacture of the device was established.

• 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
• MDR Report Key: 7270507
• MDR Text Key: 100145058
• Report Number: 1219602-2018-00221
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)220515(10)50664312
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50664312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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
• Patient Age: 46 YR