MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE

Catalog Number	71934479
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Additional information in d1, d2, d4 and d9.
Additional Manufacturer Narrative
H10: internal reference number: (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on (b)(6) 2023, the patient experienced proximal portion breakage of the nail.This adverse event was addressed by revision surgery on (b)(6) 2024, in which the entire nail was removed.Surgeon then went to remove the compression screw, which then realized the tip was broken off.He was able to remove the compression screw by sliding an osteotome inferior to the compression screw to create some space, and then he slid that same osteotome in between the lag and compression screw to separate them.He removed the lag screw and pulled the remaining compression screw out with a bulldog.He then used a stryker nail extractor to get the rest of the nail out.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated intertan nail was returned and evaluated.The visual inspection revealed that the nail fractured into two pieces.The 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 the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the instructions for use documents for intramedullary nail system revealed in possible adverse effects that cracking or fracture of the implant may occur.Preoperative planning section states that proper type and size of implant must be selected to ensure effective treatment of patients considering factors such as patient¿s size, strength, skeletal characteristics, skeletal health, and general health.Overweight or musculoskeletal deficient or unhealthy patients may create greater loads on implants that may lead to breakage or other failure of the implants.Additionally, postoperative care section warns that early weight bearing substantially increases implant loading and increases the risk of breaking the device.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.According with inspection procedure, the visual inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of standard grade titanium alloy shall be controlled.The clinical/medical investigation concluded that, based on the product evaluation, it was concluded that ¿fatigue cracking¿ was the likely cause of the reported adverse event.This can be due to the patient¿s activity levels prior to full bone union or poor bone quality.It is unknown if the instructions for use document was adhered to.Therefore, it cannot be concluded that these adverse events was a mal-performance of the implant or an implant failure.The patient impact beyond the reported fracture nail, the removal broken compression screw and the subsequent revision could not be determined since the patient¿s condition is unknown.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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: INTERTAN 10MM X 24CM 125D
• Common Device Name: 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: 18927060
• Report Number: 1020279-2024-00558
• Device Sequence Number: 13097892
• Product Code: JDS
• UDI-Device Identifier: 00885556105092
• UDI-Public: 00885556105092
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2024

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: Lay User/Patient
• Device Expiration Date: 07/13/2023
• Device Catalogue Number: 71934479
• Device Lot Number: 23GM06285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/16/2024; 07/30/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/16/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown