MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR RCI 9X25 STER; SCREW, FIXATION, BONE

Catalog Number	7207301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after surgery the staff noticed that the rci screw used in the patient was past its sterilization expiry date by 24 days.Patient outcome is unknown.
Event or Problem Description
It was reported that after an acl surgery the staff noticed that the rci screw used in the patient was past its sterilization expiry date by 24 days.Patient outcome is unknown.
Additional Manufacturer Narrative
One sterile rci 9x25mm screw product used for treatment, was not returned for evaluation.There was a relationship between the reported event and the device.Per allegation: ¿it was reported that after an acl surgery the staff noticed that the rci screw used in the patient was past its sterilization expiry date by 24 days.Patient outcome is unknown.¿ smith and nephew does not support or share responsibility with incorrect use or care of device.This includes off label use; use of product past expiration date listed on the package.It is up to the purchase agent to maintain stock which includes use of oldest product first.Product met specifications upon release to distribution.Complaint history review found no other reports for this manufacturing lot.

• Brand Name: SCR RCI 9X25 STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8586769
• Report Number: 1219602-2019-00507
• Device Sequence Number: 13912429
• Product Code: HWC
• UDI-Device Identifier: 03596010380647
• UDI-Public: 03596010380647
• 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,Followup
• Report Date (Section B): 07/04/2019

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 Catalogue Number: 7207301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 05/14/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/14/2019; 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1