MAUDE Adverse Event Report: ACUMED LLC ACU-LOC® 2 VDR PLT STD R; PLATE, FIXATION, BONE

Model Number 70-0357-S

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

Additional mdr associated with this event: 3025141-2021-00155: driver.3025141-2021-00156: screw.

Event Description

While implanting an aculoc 2 plate with a locking screw, the driver tip broke off in the head of the screw.The tip was left implanted in the patient.

• Brand Name: ACU-LOC® 2 VDR PLT STD R
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 13124497
• MDR Text Key: 285391788
• Report Number: 3025141-2021-00157
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0357-S
• Device Catalogue Number: 70-0357-S
• Device Lot Number: 515412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian