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

Model Number 72201491

Device Problem Misfire (2532)

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

Event Date 05/15/2018

Event Type  malfunction  

Event Description

It was reported that both implants, t1 and t2, got deployed when first bite was taken in the meniscus.No significant delay or patient injury reported.

Manufacturer Narrative

One 72201491 ultra fast-fix curved needle delivery system received.The complaint stated: "it was reported that both implants, t1 and t2, got deployed when first bite was taken in the meniscus.No significant delay or patient injury reported." the blue split cannula was returned covering the needle.The white depth limiter is attached and trimmed.T1, t2 were not returned.Partial torn suture was returned.The needle is twisted toward the left at the distal tip.Twisting or bending of the needle track may encourage release of t when not intended.Twisting or bending of the needle track can interfere with advancement and release of t's.The manual advancement lever was fully retracted.Ifu instructs to manually position t1 for stripping off and then separately manually push the lever again to fully position t2 for stripping off.Advancing the lever fully in one motion may prematurely release t2.No root cause related to the manufacture of the device was confirmed.

Manufacturer Narrative

Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• 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: 7587108
• MDR Text Key: 111050453
• Report Number: 1219602-2018-00714
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010597205
• UDI-Public: (01)03596010597205(17)221227(10)50704587
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Model Number: 72201491
• Device Catalogue Number: 72201491
• Device Lot Number: 50704587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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