MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX20CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71701120L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an internal fixation surgery, the hfn 11.5mmx20cm left broke above the most superior distal screw (the clac to talus screw) after it was implanted on (b)(6) 2020.Revision surgery has been schedule and rescheduled to remove.The procedure to remove has not happened yet.Patient was not harmed beyond the described event.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, used in treatment, was not returned for evaluation.However, the images were reviewed, and the breakage was confirmed.The clinical/medical investigation concluded that, the x-ray photos provided confirm the broken nail as well as articulation between the tibia and the talus which appears to have desired to be stabilized.Based on the limited information provided the root cause of the reported breakage could not be determined and early weight bearing cannot be ruled out.The impact to the patient beyond the reported cannot be concluded.Although it was communicated that a revision procedure has been schedule no date or new information has been provided.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, abnormal loading of limb or excessive forces applied to implant.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: HFN 11.5MMX20CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11922033
• Report Number: 1020279-2021-04951
• Device Sequence Number: 16938768
• Product Code: HSB
• UDI-Device Identifier: 03596010543189
• UDI-Public: 03596010543189
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K043052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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 Model Number: 71701120L
• Device Catalogue Number: 71701120L
• Device Lot Number: 20AM03376
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: Hospitalization; Required Intervention