MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 11X30 STERILE; SCREW, FIXATION, BONE

Model Number	7209014
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Unspecified Tissue Injury (4559)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.Due to current wounds in screw insertion site, the screw was removed.It was found that no degradation of the screw even after more than one and a half year.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3,h6: the reported 11x30mm biorci ha screw, used in treatment, has not been 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, the device showed no absorption after being implanted for over a year and a half.An exact root cause cannot be determined with confidence.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection revealed that the screw was returned in a small cup.The material had become brittle and had flaked off in the cup during transfer.It is likely that the biodegradable material had begun its degradation process, causing the leftover material to become brittle.There was a small chip at the proximal end.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.The instructions specified that the screw materials are often absorbed in two to six years rather than one and a half.A clinical investigation concluded that the implantation report provided did not contribute any findings to the reported issue.The future impact to the patient beyond the revision cannot be determined.Should any additional clinical information be provided this complaint will be re-evaluated.No further clinical assessment is warranted.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: SCR BIORCI-HA 11X30 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10151477
• Report Number: 1219602-2020-00908
• Device Sequence Number: 14165899
• Product Code: HWC
• UDI-Device Identifier: 03596010460189
• UDI-Public: 03596010460189
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002274
• 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): 05/04/2021

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: 11/28/2022
• Device Model Number: 7209014
• Device Catalogue Number: 7209014
• Device Lot Number: 50699577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Distributor Facility Aware Date: 05/27/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 04/30/2021
• Initial Report FDA Received Date: 06/14/2020
• Supplement Report FDA Received Date: 09/02/2020; 05/04/2021
• 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: Other
• Patient Age: 23 YR