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

Catalog Number 7207301

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/29/2019

Event Type  malfunction  

Event 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 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.

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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8586769
• MDR Text Key: 144315668
• Report Number: 1219602-2019-00507
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010380647
• UDI-Public: 03596010380647
• 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,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7207301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1