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

Model Number	7209411
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9390517
• Report Number: 1219602-2019-01507
• Device Sequence Number: 13562574
• Product Code: HWC
• UDI-Device Identifier: 03596010477972
• UDI-Public: 03596010477972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K992945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 02/22/2024
• Device Model Number: 7209411
• Device Catalogue Number: 7209411
• Device Lot Number: 2029478
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1