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

Model Number	014208
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 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.
Additional Manufacturer Narrative
Correction in h7 and h9.

• Brand Name: SCR CNFLX 1.0 6X30 STER
• Common Device Name: 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: 11455148
• Report Number: 1219602-2021-00472
• Device Sequence Number: 19612373
• Product Code: HWC
• UDI-Device Identifier: 03596010025654
• UDI-Public: 03596010025654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K921481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• 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
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 09/01/2022
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/10/2021; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1510-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown