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

Model Number	014208
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy (acl or other) set up or inspection of scr cnflx 1.0 6 x 30 ster it was found that a size of 6 mm x 20 mm screws were contained in a sterile package instead of a size of 6 mm x 30 mm.The procedure was successfully completed with another lot of back-up device.This was found before the procedure, no patient injuries and complications were reported.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 five packages of the same lot were returned together.All packaging had been opened.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.

• 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
• MDR Report Key: 11448623
• Report Number: 1219602-2021-00467
• Device Sequence Number: 19777267
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2021

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: 11/01/2025
• Device Model Number: 014208
• Device Catalogue Number: 014208
• Device Lot Number: 50906647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 10/15/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/10/2021; 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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