MAUDE Adverse Event Report: SMITH+NEPHEW LYON CORTICAL SCREW LOCK SCREW (D4.5-L45); PLATE, FIXATION, BONE

Model Number	CC045ND
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three (3) months after an internal fixation surgery had been performed on (b)(6) 2021, the heads of one (1) cortical screw lock screw (d4.5-l45) inserted distal to the osteotomy broke.A revision surgery was performed on (b)(6) 2022 to explant the screw: the intraosseous part of the screw was not removed to prevent floor damage.Drilling for the new screw was done bicortically in a somewhat more horizontal alignment.The plate was retained.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated devices were returned and evaluated, including 2 cortical screws p/n: cc040nd, lot: fw6x and p/n: cc045nd, lot: fw6y and 3 lock screws p/n: 185600nd, lot: ftrq, fw6y and ftrn.Visual inspection of the returned devices confirmed the reported breakage of the cortical screws.No further anomaly was found during the inspection of the returned products.Patient x-rays were provided that show the screws breakage, however the x-rays do not reveal the cause of the breakage.A review of complaint history for the part number over the past 4 years did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of the risk management file revealed this failure mode and associated potential hazards/harms have been previously identified.As this is the first case of a post-operative breakage for a surfix® cortical bone screw diam.4.5 mm during the last 4 years, the risk file will be reviewed to ensure the expected probability of occurrence is aligned with the actual occurrence rate and the anticipated risk level remains adequate.The complaint was confirmed and a contribution of the device to the reported event could be corroborated.However, no manufacturing, material or design issue were identified during investigation.While a definitive root cause for the breakage could not be identified, potential factors that could have contributed to the reported event include early weight bearing, a trauma or rigorous physical activity as the initial information stated the patient has downgraded his sports program.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: CORTICAL SCREW LOCK SCREW (D4.5-L45)
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH+NEPHEW LYON; immeuble sequoia 2; saint priest rhone, 69800 ; FR
• Manufacturer (Section G): SMITH+NEPHEW LYON; immeuble sequoia 2; saint priest rhone, 69800 ; FR
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15923890
• Report Number: 3002952164-2022-00015
• Device Sequence Number: 15151867
• Product Code: HRS
• UDI-Device Identifier: 10381780051152
• UDI-Public: 10381780051152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K041601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 01/01/2026
• Device Model Number: CC045ND
• Device Catalogue Number: CC045ND
• Device Lot Number: FW6Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SURFIX LOCK SCREW TI 6.5MM(PN:185600ND, LN:FTRN).; SURFIX LOCK SCREW TI 6.5MM(PN:185600ND, LN:FTRQ).; SURFIX LOCK SCREW TI 6.5MM(PN:185600ND, LN:FW6Y).; TIBIAL PLATE FOR LEFT OPENING(PN: PTOGND, LN:FUJ4).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 85 KG