MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META RETRO FEM NAIL 11.5 X 42; NAIL, FIXATION, BONE

Model Number 71653242

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post market clinical follow up activity sponsored by smith and nephew.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that the patient had a breakage of the distal interlocking screws after having a fracture fixation surgery of the left femur using the trigen retrograde femoral nail system.Also, there was what appears to be a new femoral shaft fracture surrounding nail proximal to original fracture.The patient achieved union at 27 weeks after the primary surgery.No hardware revision surgery was scheduled.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.

Manufacturer Narrative

H10 (sharing the results of investigation): given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, the information provided was obtained from a post-market clinical follow up activity and was reviewed.However, as of the date of this medical investigation, no relevant supporting clinical information has been provided for evaluation.It is noted that further information will not be provided.Based on the information provided, the patient had a breakage of the distal interlocking screws post fracture fixation surgery of the left femur, in addition to, an apparent a new femoral shaft fracture surrounding nail proximal to original fracture.According to the report, the patient achieved union at 27 weeks after the primary surgery, and no hardware revision has been scheduled.Since it was reported the current health status is unknown, the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.For the trigen intertan intertroch antegr nail screw, trigen tan/fan nail screw, trigen meta-tan troch antegr nail screw, specific identifiers were not provided, thus, a complaint history review could not be performed.A review of the instructions for use documents for intramedullary nail system revealed that care prior to bony union stablish to immobilize and/or externally support skeletal structures that have been implanted with surgical metallic implants until skeletal union is observed.Patients who are obese and/or noncompliant, as well as patients who could be pre-disposed to delayed or non-union, should have auxiliary support.Patients and nursing care providers should be advertised of these risks.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.With the results of this investigation the root cause of this event could not be determined.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition and/or surgical technique.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.H6 (corrected medical device problem code).

• Brand Name: META RETRO FEM NAIL 11.5 X 42
• Type of Device: NAIL, FIXATION, BONE
• 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: 16015553
• MDR Text Key: 305816639
• Report Number: 1020279-2022-04995
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71653242
• Device Catalogue Number: 71653242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Male