MAUDE Adverse Event Report: ACUMED, LLC 2.3MM X 16MM LKG VARIABLE ANGLE SCREW; SCREW, FIXATION, BONE

Model Number 30-2316

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

During the procedure, the head of the first screw broke off while being tightened, and the second screw threads stripped.It was not possible to remove the second screw; therefore, the head was burred down, and the procedure was completed.The broken screw pieces were discarded by the attending physician.This issue resulted in a 10 minute procedural delay.This report is related to report number 3025141-2022-00129 which is for the first screw.

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 batch/lot number is unknown.

• Brand Name: 2.3MM X 16MM 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: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 14342190
• MDR Text Key: 294667045
• Report Number: 3025141-2022-00130
• 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: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-2316
• Device Catalogue Number: 30-2316
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2022
• 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: Unknown
• Patient Sequence Number: 1