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

Model Number 30-2316

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Screw co-t2318 wouldn't lock into the plate, it was spinning.Screw 30-2316 was tried after, and was also spinning.Both parts were explanted from distal row of plate 70-0350.This issue resulted in a procedural delay of 10-15 minutes.This report is related to report number 3025141-2022-00063 on the 70-0350 plate and report number 3025141-2022-00065 on the co-t2318 screw.

• 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: 13775949
• MDR Text Key: 288039351
• Report Number: 3025141-2022-00064
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female