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 Codes	Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of a trigen hindfoot nail left was performed since the nail broke at the most superior distal screw cluster due to subtalar non-union.The nail was implanted in the patient for over a year.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured at the angled screw hole on the proximal end.The threads in the screw hole were heavily damaged.Both pieces were returned.The clinical / medical investigation concluded that, although requested, no images (x-rays or mri) or surgical reports were provided for review.Per report a revision surgery was performed due to a broken nail caused by non-union.It was communicated that the patient is doing good following the procedure.No further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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.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 file and instructions for use documents revealed this failure mode was previously identified.The potential probable cause for this event is likely a non-union.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 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: 10368906
• Report Number: 1020279-2020-03727
• Device Sequence Number: 3370563
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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 Model Number: 71701120L
• Device Catalogue Number: 71701120L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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: Hospitalization; Required Intervention