MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR RCI 8X35MM 2.0 CANN. STER; SCREW, FIXATION, BONE

Model Number 7209411

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during acl reconstruction surgery, the 8x35mm was opened but it was a 9x35mm in the packaging.The device was used on patient.A backup device was available to complete the procedure with no significant delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 7209411 rci 8x35mm screw used for treatment, was returned for evaluation.The diameter of the item returned for evaluation measured 9mm.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Although we cannot determine when or where the product was put into an 8mm shelf carton, engineering has been made aware.At this time, this is an isolated incident.If relevant information becomes available to assist with further evaluation, the complaint may be revisited.No further actions required at this time.

• Brand Name: SCR RCI 8X35MM 2.0 CANN. STER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9390517
• MDR Text Key: 168468664
• Report Number: 1219602-2019-01507
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010477972
• UDI-Public: 03596010477972
• Combination Product (y/n): N
• PMA/PMN Number: K992945
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: 7209411
• Device Catalogue Number: 7209411
• Device Lot Number: 2029478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1