MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 10MM SET SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71642938

Device Problems Mechanical Jam (2983); Osseointegration Problem (3003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  Injury  

Event Description

It was reported that, after surgery had been performed on (b)(6) 2019, and before a trigen meta tan removal, it was discovered that is not possible to remove the lag screw out due to no insertion of a compression screw.It was reported that the event will not be solved in order to protect the patient from re-fracturing the femur.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the meta-tan nail surgical technique indicates the proximal screw options for recon mode involves lag and compression screw integration.The reported inability to remove the lag screw is related to a procedural variance and is not associated with a malperformance of the implant.The patient impact cannot be determined beyond the reported meta-tan nail remaining in situ.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to procedural variance, bone ingrowth and patient anatomy.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: META-TAN 10MM SET SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12311044
• MDR Text Key: 266160837
• Report Number: 1020279-2021-06306
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556343593
• UDI-Public: 00885556343593
• Combination Product (y/n): N
• PMA/PMN Number: K092748
• 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: 09/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71642938
• Device Catalogue Number: 71642938
• Device Lot Number: 16BM04566
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention