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

Model Number 72201768

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an acl reconstruction surgery, two (2) biosure screws broke while implantation.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.

Event Description

It was reported that during an acl reconstruction surgery, two biosure screws broke while implantation.All the pieces were removed from the patient by tweezers.The procedure was successfully completed with a non-significant surgical delay using a back-up device in the originally drilled bone hole.No further complications were reported.

Manufacturer Narrative

H10 h3, h6: the reported device was received for evaluation.A visual inspection revealed that they are not in their original packaging.Both devices are fractured into several pieces and have debris on them.Based on the condition of the product material found during visual inspection, it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer specification found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical evaluation states that the ifu does caution that ¿excessive force should not be placed on the delivery instrument.The starter must be utilized with the screws to minimize screw breakage during insertion.¿ and that one undated, unlabeled photo provided shows two pieces of the broken biosure screws that confirms the reported breakage, however, the photo do not aid in determining the root cause of the reported breakage.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE HA 6MM X 20MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16444471
• MDR Text Key: 310262385
• Report Number: 1219602-2023-00271
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611642
• UDI-Public: 03596010611642
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201768
• Device Catalogue Number: 72201768
• Device Lot Number: 50947569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 62 KG