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

Catalog Number 72201491

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/09/2017

Event Type  malfunction  

Event Description

It was reported that when used the ultra fast-fix, successfully stripped off t1, but failed to strip off t2.No patient injuries were reported.

Manufacturer Narrative

One 72201491 ultra-fast-fix needle delivery system device received.The device is in damaged condition.T1, t2 and suture were not returned.The complaint indicates that t1 was removed from the patient.The blue split cannula was not returned.The depth limiter was returned.It was trimmed and attached to the delivery needle.The needle is twisted and bowed.The depth limiter and the inner sheath have been completely twisted around the delivery needle.The product has been manipulated in an aggressive fashion; not consistent with smith & nephew training or ifu.Ifu warnings states ¿do not bend delivery needle¿.Twist or bend can interfere with advancement and removal of t¿s.No root cause related to the manufacture of the device was confirmed.User error may have been a contributive factor of the event.

• 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 w william cannon drive; austin, TX 78735
• MDR Report Key: 7199456
• MDR Text Key: 97646214
• Report Number: 1219602-2018-00094
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR