MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 95/90; NAIL, FIXATION, BONE

Model Number	71677095
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
*usa legal* it was reported that 3 months after an orif of a left intertrochanteric hip fracture was performed with a trigen intertan nail system on (b)(6)2018, the patient felt a pop in her hip and had pain with difficulty ambulation.Upon arrival to the emergency room, x-rays confirmed that the lag and compression screws were noted to back out somewhat from the lateral cortex and a ct scan demonstrated a comminuted fracture of the greater trochanter.To address this adverse event, the nailing system was replaced with a tha from a competitor.Upon removal of the nail, a fracture along its midportion was noted.The patient kept experiencing other adverse events after the revision surgery that are still unresolved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation but the pictures were reviewed, and they confirm the backout of the lag and compression screw.The clinical/medical investigation concluded that, the provided x-ray and ct scan reports confirmed the backout of the lag and compression screw as well as the comminuted fracture of the greater trochanter.However, the clinical root cause of the reported events cannot be determined.The impact to the patient beyond that which has already been reported cannot be determined.However, it was noted that following the removal of the s+n components and tha conversion procedure, the patient developed foot drop, prosthetic infection, hypertensive emergency, and renal failure.These developments are most likely related to the procedure and the patient¿s previous diagnoses of type ii dm and hypertension.No further clinical assessment is warranted at this time.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 complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed that loosening has been identified as a possible adverse effect.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could be corroborated since the backout of the screws caused the replacement of the nailing system.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: LAG/COMP SCREW KIT 95/90
• 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: 13777610
• Report Number: 1020279-2022-01191
• Device Sequence Number: 1715307
• Product Code: JDS
• UDI-Device Identifier: 03596010563316
• UDI-Public: 03596010563316
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 71677095
• Device Catalogue Number: 71677095
• Device Lot Number: 18FT04552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 52 YR
• Patient Sex: Female