MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 8 MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201778
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an acl procedure, the surgeon was removing the biosure to see why it was not working, and it was found that a piece of the biosure was inside the patient.The piece was left inside the patient.Backup device was available to complete the procedure.No delay and the patient outcome is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 review of risk management files found that the reported failure was documented appropriately.A review of the customer provided images found packaging confirming the product identification information.The screw is fractured and is missing the distal tip.There is debris in the threads of the screw.Per the surgeon's report, it was confirmed, "a piece of the biosure was inside the patient was left inside of the patient." no clinically relevant supporting documentation was provided for review.The broken piece of the biosure screw that is retained inside the patient, is made of a bio-composite material which is intended for implantation to allow for bone ingrowth.However, we cannot rule out the potential for inflammation and/or pain, migration/and or micro-motion of the retained piece.According to the report, a backup device was available to complete the procedure without a delay, although, the patient outcome is unknown.Should any additional medical information be provided, this complaint would be re-assessed.The complaint was confirmed.Factors that could have contributed to the reported event 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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: BIOSURE HA 8 MM X 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12445035
• Report Number: 1219602-2021-01905
• Device Sequence Number: 3516922
• Product Code: HWC
• UDI-Device Identifier: 03596010611741
• UDI-Public: 03596010611741
• Combination Product (Y/N): N
• PMA/510(K) Number: K080358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2025
• Device Model Number: 72201778
• Device Catalogue Number: 72201778
• Device Lot Number: 50895550
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention