MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 85/80; NAIL, FIXATION, BONE

Catalog Number	71677085
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.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 screws were returned and evaluated.The visual/macroscopic inspections revealed that the compression screw was observed to have fractured within the patient.The other two screws have gouges and burrs with no further signs of fractures or defects.These screws show signs of wear.It is not clear what initiated the screw breakage.No material or manufacturing deviations were observed during this investigation.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 documents were 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.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the lag/compression screw kit.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 that cracking or fracture of the implant components has been identified in possible adverse effects section.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 material specification, the quality and manufacture of standard grade titanium alloy shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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: LAG/COMP SCREW KIT 85/80
• 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: 18927134
• Report Number: 1020279-2024-00559
• Device Sequence Number: 4479246
• Product Code: JDS
• UDI-Device Identifier: 03596010563293
• UDI-Public: 03596010563293
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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 Catalogue Number: 71677085
• Device Lot Number: 22GT65391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/10/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIGEN LO PROF SCRE 5.0MMX35MM:71645035,23KM08245
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown