MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 8X35 STERILE; SCREW, FIXATION, BONE

Catalog Number 7207680

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/03/2019

Event Type  malfunction  

Event Description

It was reported that during procedure, the screw that was used on the patient had 2 labels on the box: 9x25 & 8x25.Surgeon wanted to use a 9x25, but since the patient was on tourniquet, they had to hurry and complete the procedure with the screw.No significant delay and no patient injuries were reported.

Manufacturer Narrative

One sterile 8x35mm biorci-ha screw used for treatment, but was not returned for evaluation.The complaint stated: ¿the screw that was used on the patient had 2 labels on the box: 9x25 & 8x25.Surgeon wanted to use a 9x25, but since the patient was on tourniquet, they had to hurry and complete the procedure with the screw.¿ the product was not returned.The complaint allegation was confirmed via an attached customer video clip.The in-country (applied) label does not correlate with the original manufacturing label.The complaint allegation is for a condition that smith and nephew has been made aware of.It is not a physical product defect, but a label file technical disparity.Secondary labels applied during the distribution process contained alternate information pulled from data files which did not correlate with original manufacturing labels attached.The secondary labels for outside the united states; india shipments called an ¿in-country¿ label.

• Brand Name: SCR BIORCI-HA 8X35 STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8814655
• MDR Text Key: 151853723
• Report Number: 1219602-2019-00856
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K002274
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7207680
• Device Lot Number: 50718202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1