MAUDE Adverse Event Report: ACUMED LLC 2.3MM X 22MM LKG VARIABLE ANGLE SCREW; SCREW, FIXATION, BONE

Model Number 30-2322

Device Problem Scratched Material (3020)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00257: screw 1, 3025141-2020-00259: driver.

Event Description

While being implanted, two 2.3 variable ange screws stripped.One screw was removed with an easy out.The other screw was left in.This caused a 15 minute delay in surgery.

• Brand Name: 2.3MM X 22MM LKG VARIABLE ANGLE 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 10759790
• MDR Text Key: 215289514
• Report Number: 3025141-2020-00258
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-2322
• Device Catalogue Number: 30-2322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• 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