MAUDE Adverse Event Report: ACUMED LLC ACU-LOC® VDU PLATE LEFT STD; PLATE, FIXATION, BONE

Model Number CO-T2312-S

Device Problems Break (1069); Sticking (1597)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The returned product was observed with the naked eye, but because the part does not indicate where the screw with the issue was located.Additional mdrs associated with this event: 3025141-2017-00318: screw, 3025141-2017-00320: driver.

Event Description

During routine removal of an ulna plate, it was discovered that the head of one of the screws had turned black.While attempting to remove the black screw, it was determined that a driver tip was left in the screw head from the initial surgery.The screw with the driver tip was explanted; the screw was severly damaged during removal.

• Brand Name: ACU-LOC® VDU PLATE LEFT STD
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7126346
• MDR Text Key: 95730569
• Report Number: 3025141-2017-00319
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2017

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: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: CO-T2312-S
• Device Catalogue Number: CO-T2312-S
• Device Lot Number: 358491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2015
• 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