MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8MM X 25MM; SCREW, FIXATION, BONE

Catalog Number 72201776

Device Problems Material Fragmentation (1261); Device Slipped (1584); Extrusion (2934)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Patient¿s age reported as approximately (b)(6).Implant date reported as approximately five years ago.(b)(6).(b)(4).

Event Description

Patient received acl surgery five years ago.Patient is now experiencing pain and swelling over tibia.The doctor can penetrate the tibial screw.Patient received a new surgery.The device has backed out of the insertion site and is now raised above the bone i.E., "proud." the initial surgical procedure was completed with no issues.The revision surgery has already been performed and the outcome was fragmenting of the screw which penetrated the skin.

Manufacturer Narrative

Small fragments from an 8mmx25mm biosure ha screw were returned for evaluation.The returned fragments were examined and it was determined that due to 5 years of implantation and the size of the returned sample we are unable to determine a root cause for this incident.A review of the complaint records indicates this incident to be isolated in nature.(b)(4).

• Brand Name: BIOSURE HA 8MM X 25MM
• 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: 5148534
• MDR Text Key: 28223462
• Report Number: 1219602-2015-01065
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2015
• Device Catalogue Number: 72201776
• Device Lot Number: 50347269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2010
• 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
• Patient Outcome(s): Required Intervention