MAUDE Adverse Event Report: ACUMED, LLC 2.7 X 12MM L LOW PROFILE HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 3040-23012-S

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Date 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Manufacturing and inspection records could not be reviewed as the device batch/lot number is unknown.

Event Description

It was reported during a routine removal procedure, one of the screws was firmly "adhered" to the plate.When attempting to remove this screw, two drivers broke.The surgeon had to cut the plate in order to remove the hardware.This issue prolonged the procedure by 45 minutes.It was reported the patient remained stable, and no other adverse patient consequences were reported.This report is related to report numbers 3025141-2023-00014 and 3025141-2023-00015 for the other devices involved in this event.

• Brand Name: 2.7 X 12MM L LOW PROFILE HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 16205411
• MDR Text Key: 308933358
• Report Number: 3025141-2023-00016
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3040-23012-S
• Device Catalogue Number: 3040-23012-S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Race: Asian