MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 6MM X 20MM; SCREW, FIXATION, BONE

Catalog Number 72201768

Device Problem Expiration Date Error (2528)

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

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, for an acl reconstruction, an expired biosure ha implant was used.As a revision surgery has not been deemed necessary, the implant remains in the patient.Neither adverse events nor other consequences have been stated.

Manufacturer Narrative

One 72201768 6x20mm biosure ha screw product reported on.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.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6), medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional information be provided this complaint will be re-assessed.

• Brand Name: BIOSURE HA 6MM X 20MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8620051
• MDR Text Key: 145488069
• Report Number: 1219602-2019-00563
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611642
• UDI-Public: 03596010611642
• Combination Product (y/n): N
• PMA/PMN Number: K080358
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 72201768
• Device Lot Number: 50485191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1