MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW TAP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674009

Device Problems Material Deformation (2976); Naturally Worn (2988)

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

Event Date 05/04/2021

Event Type  malfunction  

Event Description

It was reported that, during a trauma procedure, it was noticed that the following instruments of the trigen¿ intertan¿ instrument set are warped due to wear and tear over past 3 years: lag screw drill sleeve (case-(b)(4)), intertan 3. 2mm guiide pin sleeve (case-(b)(4)), lag screw tap (case-(b)(4)), lag screw driver (case-(b)(4)), compression screw hexdriver (case-(b)(4)), subtroc lag screw driver (case-(b)(4)), 130 rad drill gde drop (case-(b)(4)), unknown trigen instrument (case-(b)(4)), unknown trigen instrument (case-(b)(4)). The procedure was able to be completed with the same device. Surgery was greater than 30-mins delayed. Patient was not harmed.

• Brand Name: LAG SCREW TAP
• 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: 11853760
• MDR Text Key: 251655087
• Report Number: 1020279-2021-04512
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71674009
• Device Catalogue Number: 71674009
• Device Lot Number: 07KHU0011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse