MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN PERC DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631021

Device Problem Failure to Align (2522)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that, during a trigen tan surgery, the doctor faced several issues with its instruments. Also, there was mismatch/alignment between hole and drill bit. Surgery was resumed, with a greater than 30 minutes delay, with a competitor device. Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a trigen tan surgery, the doctor faced several issues with its instruments. Also, there was mismatch/alignment between hole and drill bit. Surgery was resumed, with a greater than 30 minutes delay, with a competitor device. Patient was not harmed as consequence of this problem.

• Brand Name: TAN/FAN PERC DRILL GUIDE
• 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: 13113696
• MDR Text Key: 285327935
• Report Number: 1020279-2021-08964
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71631021
• Device Catalogue Number: 71631021
• Device Lot Number: 17GSP0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown