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 product was used for a ¿meniscus repair¿ procedure.The complaint said: ¿the ultra fast-fix, successfully stripped off t1, but failed to strip off t2¿.The device is in used condition and has evidence of surgical remains attached.T1 was not returned.T2 and remains of cut suture are still attached to device.The delivery needle is slightly bowed and twisted at the needle tip.Ifu warnings states: ¿do not bend delivery needle.¿ twist or bend can interfere with proper delivery of anchors.Under magnification it is apparent that t2 has tissue wedged underneath it which is binding it in the needle track.The t is lifted at the anterior tip, up out of the track and wedged it in that position.Once tissue was freed t2 was lowered into the track and released as intended.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 w william cannon drive; austin, TX 78735
• MDR Report Key: 7199450
• MDR Text Key: 97770860
• Report Number: 1219602-2018-00096
• 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