MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72202624

Device Problems Break (1069); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an unknown procedure that the physician was going to use a device made of peek material, however, he used a biocompatible material.The device broke inside the patient.The broken piece was completely removed by an arthroscopy method and the patient is stable.It was noticed that there were two labels on the device.The origin label which is placed by the manufacturing site had no problems.The secondary label, which is placed in the destination country due to a local regulatory requirement, was wrongly placed on the device.The secondary local label stated that the product was peek, when the product was actually composed of a biocompatible material.The device was disposed of.A backup of the same type was used to complete the procedure.No holes were left empty and the site was prepped with a drill.

Manufacturer Narrative

Evaluation was not possible, as the device will not be returned.The reported breakage cannot be confirmed.A photograph was supplied of the labeling issue.Visual assessment of the photo showed a shelf carton with two labels affixed.One label was affixed by smith+nephew during manufacture which was labeled correctly as a twinfix ha.A secondary label was affixed on the shelf carton by smith + nephew (b)(4) due to local regulatory requirements.This label indicates that the product is a twinfix pk which is incorrect.It appears that an input error took place during this process at the local smith+nephew office in (b)(4).This event was investigated, and it was determined that it was an isolated incident.A labeling procedure has been implemented to prevent a reoccurrence.No additional actions are required at this time.(b)(4).

• Brand Name: TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5365364
• MDR Text Key: 36106450
• Report Number: 1219602-2016-00025
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K093844
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2019
• Device Catalogue Number: 72202624
• Device Lot Number: 50526395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2014
• 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