MAUDE Adverse Event Report: ACUMED LLC ACU-LOC® 2 VDR PROX PLT, NARROW, L; PLATE, FIXATION, BONE

Model Number 70-0352

Device Problem Split (2537)

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

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

The returned plate was examined visually.Two small marks can be seen in the slot indicating a non-locking screw was seated and tightened to the plate.Additional mdrs associated with this event: 3025141-2017-00187: screw.

Event Description

When the doctor was implanting an acu-loc 2 vdr plate, the insertion of a screw into the plate slot caused the radius shaft to split.The plate was replaced with a longer plate.

• Brand Name: ACU-LOC® 2 VDR PROX PLT, NARROW, L
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432
• MDR Report Key: 6814989
• MDR Text Key: 83628638
• Report Number: 3025141-2017-00186
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 70-0352
• Device Catalogue Number: 70-0352
• Device Lot Number: 341426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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
• Patient Age: 59 YR