MAUDE Adverse Event Report: ACUMED, LLC 4.3MM X 38MM LOW PROFILE HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 3011-43038-S

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.

Event Description

It was reported the patient who had undergone polarus 3 surgery fell and re-fractured (event date unknown).The polarus 3 implant procedure was performed in (b)(6) 2021.The nail itself was also broken near the distal screw of the nail.The surgeon explanted the polarus3 nail.This report is related to report numbers 3025141-2022-00210, 3025141-2022-00211, 3025141-2022-00212, and 3025141-2022-00214 for the other devices involved in this event.

• Brand Name: 4.3MM X 38MM 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: 14983295
• MDR Text Key: 295678724
• Report Number: 3025141-2022-00213
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131636
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3011-43038-S
• Device Catalogue Number: 3011-43038-S
• Device Lot Number: 502250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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 Outcome(s): Other
• Patient Race: Asian