MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 10MM X 36CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71640636

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 12/15/2021

Event Type  Injury  

Event Description

It was reported that, after a trauma surgery had been performed on 2019, the patient experienced a non-union of a subtrocantheric fracture.This adverse event was solved by revision surgery perform on (b)(6) 2021, in which the meta-tan 10mm x 36cm right, and the set of screws: trigen low profile screw 5.0mm x 40mm, trigen low profile screw 5.0mm x 45mm and meta-tan lag/comp kit 95/90 were explanted.The current health status of patient is unknown.It is suspected that patient has a bone disease because she has a couple of fractures caused by low energy forces.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that smith and nephew has not received the device/adequate clinically relevant documentation to fully evaluate the complaint.Therefore, the root cause and/or patient outcome beyond that which has already been reported could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinically relevant materials be later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.The contribution of the device to the reported event could not be corroborated.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.Additional device were reported under mdr reports: -1020279-2022-00035 -1020279-2022-00036 -1020279-2022-00037 b5.

• Brand Name: META-TAN 10MM X 36CM RIGHT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13152447
• MDR Text Key: 283154299
• Report Number: 1020279-2022-00034
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556340240
• UDI-Public: 00885556340240
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71640636
• Device Catalogue Number: 71640636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female