MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 25MM; SCREW, FIXATION, BONE

Model Number 72201772

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 05/29/2020

Event Type  Injury  

Event Description

It was reported that during a procedure the point of the screw broke when it was being fixed in the tibial tunnel.The procedure was successfully completed with a backup device and no delay was reported.No further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h6.The reported 7x25mm biosure ha screw, used in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, screw broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site per the instructions for use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found an anchor with a broken tip and debris.No indications from the device show cause that the material is related to the reported failure.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were 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 review of the raw material, found that the storage protocols, material specifications, and material tests were appropriately documented.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or torque, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE HA 7MM X 25MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10165320
• MDR Text Key: 195522044
• Report Number: 1219602-2020-00932
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010611680
• UDI-Public: 03596010611680
• 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,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72201772
• Device Catalogue Number: 72201772
• Device Lot Number: 50811720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention