MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 40MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71645040

Device Problem Break (1069)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 03/01/2018

Event Type  Injury  

Event Description

It was reported that the nail broke inside the bone, patient had instability so a revision surgery was performed and the nail was removed.

Manufacturer Narrative

The associated complaint device was returned for evaluation.A visual inspection of the trigen low profile screw revealed no obvious defects.The device exhibits signs of attempted use.Clinical analysis determined that based on the images provided and the supporting lab retrieval analysis, it is concluded that the highly unstable non-union and incomplete anatomical reduction were contributing factors to the reported event.The patient impact beyond likely pain and the reported revision procedure cannot be determined.No further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.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.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 40MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7449537
• MDR Text Key: 106133940
• Report Number: 1020279-2018-00790
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556215791
• UDI-Public: 00885556215791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71645040
• Device Lot Number: 17FM08066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention