MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

Device Problems Material Fragmentation (1261); Device-Device Incompatibility (2919)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the procedure when inserting the locking screw of aculoc 2, the screw did not fully seat into the plate, and a piece of metal emerged from the screw.The screw was disposed of at the hospital, and device information for the plate (model number, batch/lot number) is unknown.There were no adverse consequences for the patient and no delay in procedure.This report is related to report number 3025141-2022-00161 for the screw involved in this event.

• Type of Device: PLATE, 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: 14579249
• MDR Text Key: 294672289
• Report Number: 3025141-2022-00162
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/02/2022
• 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