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

Model Number 71674067

Device Problems Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983)

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

Event Date 04/12/2021

Event Type  malfunction  

Event Description

It was reported that, during a trauma hip surgery the scrub tech inserted the wrong capture stick into the lag screw driver and now it¿s stuck on the lag/comp screw kit 90/85 and won¿t come out. It was unknown how the procedure was finished and if there was a surgical delay. No patient injuries or other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation. A visual inspection was conducted and confirmed the tech inserted the wrong capture stick into the lag screw driver and now it¿s stuck on the lag/comp screw kit 90/85 and won¿t come out. This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur. Expected wear/tear is likely the probable cause of the reported event. We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary. 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 complaints will be reopened. No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed.

• 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: 11797445
• Report Number: 1020279-2021-03904
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560605
• UDI-Public: 03596010560605
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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: 14JSP0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse