MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 13X26 130D LT; NAIL, FIXATION, BONE

Model Number 71676611

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 12/26/2018

Event Type  Injury  

Event Description

It was reported that a female patient had an intertan surgery.After the surgery surgeon found out there was fracture around distal screws, he thinks the diameter of the part under the screw head is wide and the diameter of drill is not fit for it.

Manufacturer Narrative

The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the images provided confirm the reported.Based on the limited information provided the root cause of the fracture could not be determined and no conclusion can be made on if the use of longer screws can prevent the fracture.The impact to the patient beyond the reported issue cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: INTERTAN 1.5 13X26 130D LT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9938382
• MDR Text Key: 187044626
• Report Number: 1020279-2020-01231
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556039274
• UDI-Public: 00885556039274
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 71676611
• Device Catalogue Number: 71676611
• Device Lot Number: 18CM01525
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR