MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX16CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71701116R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the locking screw was not inserted through the nail that goes from the calcaneus to the cuboid.It was verified that the system was correctly mounted and no failure was found.It is presumed that the failure occurred in the inserted nail but was not confirmed.Procedure was concluded with a delay of less than 30 minutes with the same nail.No other screw was placed so a void was left in the bone.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not received for evaluation.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.However, the images provided were reviewed, and the mispositioning was confirmed.The clinical/medical investigation concluded that, the undated image provided was reviewed and does not lead to a root cause conclusion.Based on the limited information provided the root cause of the reported issue cannot be determined.It was noted that since the locking screw was not able to be inserted a void was left in the patient and the impact to the patient is expected to be minimal.Should additional information become available this issue can be re-elevated.No further clinical/medical 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.Possible causes could include but are not limited to alignment, procedural variance or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: HFN 11.5MMX16CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10814877
• Report Number: 1020279-2020-06335
• Device Sequence Number: 1872274
• Product Code: HSB
• UDI-Device Identifier: 03596010543172
• UDI-Public: 03596010543172
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K043052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71701116R
• Device Catalogue Number: 71701116R
• Device Lot Number: 19CM15460
• Initial Date Received by Manufacturer: 10/17/2020
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 10/14/2021
• 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: Required Intervention