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

Model Number 71674067

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 ((b)(4)), intertan 3. 2mm guiide pin sleeve ((b)(4)), lag screw tap ((b)(4)), lag screw driver ((b)(4)), compression screw hexdriver ((b)(4)), subtroc lag screw driver ((b)(4)) 130 rad drill gde drop ((b)(4)), unknown trigen instrument ((b)(4)), unknown trigen instrument ((b)(4)). The procedure was able to be completed with the same device. Surgery was greater than 30mins delayed. Patient was not harmed.

• Brand Name: LAG SCREW DRIVER
• 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: 11861860
• MDR Text Key: 252000053
• Report Number: 1020279-2021-04563
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71674067
• Device Catalogue Number: 71674067
• Device Lot Number: 07FSP0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage