MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 11MM X 30MM; SCREW, FIXATION, BONE

Catalog Number 72201789

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device is not being returned.A review of the device history records identified that the date of manufacture of the device was 03/23/2009 and the material expiry date was 02/28/2014.The root cause of the reported incident cannot be attributed to a manufacturing or shipment error.No further action is required.(b)(4).

Event Description

It was reported that after having performed an acl/pcl/mcl procedure using biosure ha 11mm x 30mm and after implantation of the device, it was discovered that the device expiration date had expired.It was decided to proceed with the closure of the skin.This incident did not result in any patient injury or complications.

• Brand Name: BIOSURE HA 11MM X 30MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4944879
• MDR Text Key: 23111971
• Report Number: 1219602-2015-00513
• Device Sequence Number: 1
• Product Code: HWC
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/27/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 72201789
• Device Lot Number: 50285556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Date Device Manufactured: 03/23/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1