MAUDE Adverse Event Report: ACUMED LLC 8MM POLARUS® CAP SCREW ASSEMBLY; INSTRUMENT, CAP SCREW

Model Number HR-0028-S

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Returned product examined visually under magnification.First thread has been deformed and rolled back.This deformation is likely due to cross-threading of the parts combined with excessive torque.Cross-threading is more likely on shorter parts due to the difficulty in aligning the axes.Additional mdrs associated with this event: 3025141-2018-00332: nail.

Event Description

While attempting to attach the cap screw to the polarus plus humeral rod, it was noticed that there was no polyethylene insert in the cap screw.The insert was looked for and was not found.It is not known if the insert was left behind in the patient or if it was never present.

• Brand Name: 8MM POLARUS® CAP SCREW ASSEMBLY
• Type of Device: INSTRUMENT, CAP SCREW
• 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 lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5032071387
• MDR Report Key: 8099906
• MDR Text Key: 128585609
• Report Number: 3025141-2018-00331
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013616
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: HR-0028-S
• Device Catalogue Number: HR-0028-S
• Device Lot Number: 336851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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