MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 10X26 130D RT; NAIL, FIXATION, BONE

Model Number 71676524

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 05/15/2020

Event Type  Injury  

Event Description

It was reported that an intertan was implanted 7 months ago.After that, the patient presented symptoms of pain in the hip while walking.X-rays were taken of the operative hip and these revealed that the worm drive screw was broken.The distal inter-locking screw was removed followed by the driving end of the broken worm drive screw.The femoral neck was then resected and removed thus exposing the lag screw and the remain portion of the broken worm drive screw.Next, the nail was removed.At this point, it was dicovered that the proximal end of the nail was also broken at the lag screw hole.The rest of the nail was removed and the patient received a total hip.All inter tan implants were removed.

Manufacturer Narrative

It was reported that an intertan was implanted 7 months ago.After that, the patient presented symptoms of pain in the hip while walking.X-rays were taken of the operative hip and these revealed that the worm drive screw was broken.The distal inter-locking screw was removed followed by the driving end of the broken worm drive screw.The femoral neck was then resected and removed thus exposing the lag screw and the remain portion of the broken worm drive screw.Next, the nail was removed.At this point, it was discovered that the proximal end of the nail was also broken at the lag screw hole.The rest of the nail was removed and the patient received a total hip.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Some potential causes of the reported event could include but are not limited to traumatic injury, size of device used or abnormal loading of limb.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 1.5 10X26 130D RT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10150916
• MDR Text Key: 195072258
• Report Number: 1020279-2020-02375
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556039779
• UDI-Public: 00885556039779
• Combination Product (y/n): N
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71676524
• Device Catalogue Number: 71676524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention