MAUDE Adverse Event Report: 7/16 GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674071

Device Problem Mechanical Jam (2983)

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

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during trauma surgery, the surgeon was unable to unscrew a trigen 7/16 guide bolt and remove the alignment drill guide.Excessive force was used to loosen the trigen 7/16 guide bolt, which led to breakage of a trigen guide bolt wrench.The tip of the trigen guide bolt wrench got stuck inside the trigen 7/16 guide bolt.The issue was solved by drilling a hole through the trigen 7/16 guide bolt with a metal bur.The alignment guide was removed with a back-up guide bolt wrench.A significant delay was caused as consequence of this problem.No patient injury reported.

Manufacturer Narrative

G3, h2, h3, and h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned 7/16 guide bolt confirms the threads are damaged on the device, rendering the device inoperable.The device exhibits signs of extreme wear and usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.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: 7/16 GUIDE BOLT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• MDR Report Key: 12543934
• MDR Text Key: 273745192
• Report Number: 1020279-2021-07269
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560643
• UDI-Public: 03596010560643
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674071
• Device Catalogue Number: 71674071
• Device Lot Number: 20BM07999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention