MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR CNFLX 1.0 6X30 STER; SCREW, FIXATION, BONE

Model Number 014208

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, when opening a sterile package of "6mm x 30mm screws"'; a size of 6mm x 20mm screw were contained instead of the one of size "6mm x 30mm".No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

G4, h2, h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that four devices of the same batch number were returned.None had been removed from the original packaging.The devices were found to be 6mm x 20mm instead of the specified 6mm x 30mm.A review of the device records found that the reference materials used to create and verify the dimensions of this batch were used incorrectly, leading to incorrect specifications for this work order.A complaint history review concluded this was a repeat issue.A review of the drawing found that the dimensions and specifications for of three products were contained in the same document.This product was specified to be 6mm x 30mm.The complaint was confirmed and the root cause was associated with manufacturing.Corrective actions have been initiated and are in progress to recall the batch from the field.

Manufacturer Narrative

Correction in h7 and h9.

• Brand Name: SCR CNFLX 1.0 6X30 STER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11455149
• MDR Text Key: 238928950
• Report Number: 1219602-2021-00474
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010025654
• UDI-Public: 03596010025654
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K921481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014208
• Device Catalogue Number: 014208
• Device Lot Number: 50906647
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1510-2021
• Patient Sequence Number: 1