MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE HA 7MM X 30MM; SCREW, FIXATION, BONE

Model Number	72201774
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, when using the screw, it broke inside the corticol.Kelly clamp was used to remove it.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 72201774 biosure ha 7mm x 30mm, intended for use in treatment, has not returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.From the information provided, ¿during the procedure, when using the screw, it broke inside the corticol.Kelly clamp was used to remove it¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was performed, no other complaints of this failure was found.
Additional 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 the screw is broken.Based on the condition of the product material found during visual inspection it was determined that additional material testing was not required.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.Clinical evaluation found that no further medical assessment is warranted at this time.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 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10221479
• Report Number: 1219602-2020-00969
• Device Sequence Number: 16961653
• Product Code: HWC
• UDI-Device Identifier: 03596010611703
• UDI-Public: 03596010611703
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 08/18/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: 72201774
• Device Catalogue Number: 72201774
• Device Lot Number: 50746137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 08/16/2021
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/19/2020; 08/18/2021
• 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