MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 130D; NAIL, FIXATION, BONE

Catalog Number 71934480

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

It was reported that the item broke at the point of the lag/compression screw combo.It broke inside the patient, and all pieces were recovered.Back-up used to complete the procedure.No delay or injury reported.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection was performed and confirmed that the intertan nail fractured by the initiation and subsequent propagation of shear forces.The fracture likely initiated on the lateral side of the nail through the proximal hole.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.No material deviations were found during this investigation.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.Factors and/or probable causes that could contribute to the reported event have been identified in the risk management file, such as fracture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: INTERTAN 10MM X 24CM 130D
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9318093
• MDR Text Key: 166356655
• Report Number: 1020279-2019-04011
• Device Sequence Number: 1
• Product Code: JDS
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71934480
• Device Lot Number: 19CM09908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1