MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW RCI 7X25MM STRL.; SCREW, FIXATION, BONE

Model Number	7207030
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a revision hamstring to btb acl patella tendon surgery, the rci screw in the femur was difficult with regard to obtaining a good pull-in purchase with the threads, but the screw in the tibia simply pushed the bone block through the tunnel, making the construct too loose once the screw was seated.This resulted in the need to remove the screw and retention the graft, risking damage to the graft as well as the bone tunnel.The graft was removed from the patient, checked, re-prepared and then re-implanted.This resulted in the sutures on the tibia end of the graft breaking and needing to be replaced.The procedure was successfully completed using a soft-skill screw.It is unknown if there was any delay.No other complications were reported.
Additional Manufacturer Narrative
H3, 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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.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.No relevant supporting clinical information has been provided to assist with a clinical investigation and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A relationship, if any, between the subject device and the reported event could not be determined.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: SCREW RCI 7X25MM STRL.
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11850254
• Report Number: 1219602-2021-01173
• Device Sequence Number: 19774695
• Product Code: HWC
• UDI-Device Identifier: 03596010252821
• UDI-Public: 03596010252821
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 06/27/2025
• Device Model Number: 7207030
• Device Catalogue Number: 7207030
• Device Lot Number: 2057129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1