MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X25MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207560
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient had the first surgery on (b)(6) 2017, in which a "biorci screw (8x25mm)" was implanted in him.However, the patient consulted on (b)(6) 2020 for discomfort in the implant insertion area (tibia).Signs of ulceration and extrusion of the implant were evident, and according to the specialist, the issue was attributed to the implant.Since this is a bio-absorbable screw, the specialist did not understand why approximately 33 months after the initial implantation, this has not yet completed its biodegradation.As a result of the ulceration, the patient went into a second surgery, in which during the procedure, the intact and complete screw was retrieved, but in the process of cleaning the implant to lower its bio-burden, it was noticed to be fragmented into several parts.The procedure was successfully completed and the evolution of the patient condition is satisfactory.No complications were reported in the surgical act.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images confirmed the presence of irritation.The removed screw was intact at the distal end at removal, but a few broken proximal fragments were retrieved.It appeared that the screw fractured lengthwise after cleaning, indicating that the degradation process may have been underway.A visual inspection revealed that the device was returned in a plastic cup.There were many brittle fractured pieces, as well as a fine dust, indicating that the material had already begun its degradation process before it was rejected by the patient's immune system and removed.It is likely that it became more brittle after it dried, allowing it to break apart during cleaning.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.The sterilization records were reviewed and found to include the appropriate sterilization processes.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 clinical investigation found that following implantation the biosure screw was explanted due to discomfort, ulceration, and extrusion of the implant.The instructions for use note that "as with any bio-absorbable implant, there is a chance of an inflammatory response during the degradation period of the device.¿ it was communicated via e-mail that the patient's health is stable.Since no further harm is anticipated no further clinical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with an inherent risk of the device.Immune response to the material degradation is well documented in the contraindications and risk management files.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10687309
• Report Number: 1219602-2020-01588
• Device Sequence Number: 3124241
• Product Code: HWC
• UDI-Device Identifier: 03596010426222
• UDI-Public: 03596010426222
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 08/22/2022
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50681087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 04/30/2021
• 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