MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number 72200750

Device Problem Material Separation (1562)

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

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zipcode: (b)(6).

Event Description

It was reported that, during a meniscal repair surgery, the 2.8 mm twinfix titanium screw was found fractured when inserted after pre-drilling.All fragments were retrieved from the patient.A back-up device was used in the same bone hole in order to secure fixation.The surgery was not significantly delayed.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72200750 twinfix ti 2.8mm ultrabraid suture anchor device was used for treatment and returned for evaluation.The anchor was returned freed from the device shaft.Suture was wound on the cleats.There is no bow of the insertion shaft, however, the hex has anchor material broken off inside.The anchor was fractured from rotational torque.The material inside the hex is the anchor eyelet head.There was clear damage to the anchor.There are surface gouging on the threads.There was skiving of the threads as well, creating sharp shards.The symptoms are aligned with contact with another instrument or tool along with excess force applied.Per instructions for use technique driven specific instructions: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Breakage of suture anchor can occur if predrilling is not performed prior to implantation.Excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.If more torque is required to insert the anchor, stop and ensure that the anchor size, drill hole size, and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the drill hole size to achieve optimal insertion force.It is the responsibility of the surgeon to determine the patient's bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Using the appropriate smith and nephew drill bit and drill guide (each sold separately), prepare the anchor insertion site (refer to the use of smith and nephew drill bits and drill guide sections of this document).¿ product met specifications upon release to distribution.No root cause related to the manufacture of this device can was confirmed.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9270698
• MDR Text Key: 164824416
• Report Number: 1219602-2019-01360
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Catalogue Number: 72200750
• Device Lot Number: 50739487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 67