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

Model Number	7207560
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during arthroscopy procedure, inside the patient with the scr biorci 8x25mm strl bx 1, the screw started disintegrate and some pieces were left at the tibial tunnel.The screw was removed and the tibial tunnel was washed.The procedure was finished a smith and nephew back up device.No surgical delay.No other complications 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 device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the distal tip of the screw was broken and deformed.There was evidence of bending at the break.There was no debris.Based on the condition of the product material found during visual inspection it was determined that additional material testing is 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 material specifications found that the necessary material characteristics and testing methods to verify characteristics are documented.The material certificate of analysis is required.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or bending or improper preparation of the insertion site.

• 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: 11580114
• Report Number: 1219602-2021-00719
• Device Sequence Number: 11857701
• Product Code: HWC
• UDI-Device Identifier: 03596010426222
• UDI-Public: 03596010426222
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 12/06/2024
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50844134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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