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

Model Number	71676524
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10150916
• Report Number: 1020279-2020-02375
• Device Sequence Number: 2319070
• Product Code: JDS
• UDI-Device Identifier: 00885556039779
• UDI-Public: 00885556039779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71676524
• Device Catalogue Number: 71676524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 12/13/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention