MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 10MMX20CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71701020R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, following a right hindfoot arthrodesis procedure performed on (b)(6) 2023, the nail broke at the distal locking end.The patient was scheduled for a revision on (b)(6) 2023, but the surgery was cancelled because the patient wanted a second opinion from another physician.The current patient health status is unknown.
Additional Manufacturer Narrative
Additional information: d6b (explanted date), h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated devices were returned and evaluated.A visual inspection of the returned nail reveals the nail fractured at the distal locking end.The fractured piece was returned.The visual also reveals several screws were returned and the show normal wear.The im nail fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the nail could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking was likely caused by the nail bearing cyclic stresses more than the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that although the provided x-rays confirm the reported breakage of the nail, it does not contribute to the clinical investigation of the root cause of the breakage nor assess the impact to the patient.The instructions for use warns that the device does not replace normal health bone, and that the implant can break or become damaged as a result of strenuous activity or trauma.Additionally, improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent early failure/fracture of the components.Therefore, a procedural variance or trauma cannot be ruled out as contributing factors to the reported breakage.The patient impact beyond the revision surgery cannot be determined based on the lack of information.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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.We consider this investigation closed.Corrected data: b5 (narrative updated), d9&h3 (sample returned for analysis), h6 (health effect - impact code).
Event or Problem Description
It was reported that, following a right hindfoot arthrodesis procedure performed on (b)(6) 2023, the nail broke at the distal locking end.The patient underwent a revision on (b)(6) 2023 at the schulthessklinik zürich.The current patient health status is unknown.

• Brand Name: HFN 10MMX20CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17789973
• Report Number: 1020279-2023-01818
• Device Sequence Number: 12325495
• Product Code: HSB
• UDI-Device Identifier: 03596010542496
• UDI-Public: 03596010542496
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K043052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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
• Device Catalogue Number: 71701020R
• Device Lot Number: 22DM08936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female