MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW, CANN, BLUNT TIP, 4 X 34 MM; PIN, FIXATION, SMOOTH

Model Number LO-PRO SCRW, CANN, BLUNT TIP, 4 X 34 MM

Device Problem Failure to Align (2522)

Patient Problem Fall (1848)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported on (b)(6) 2021 by a sales rep via email that an ar-1370a-s patella sutureplate¿ ii was being used in a case.After placing two 4.0 cannulated screws and fibertape to revise a transverse patella fracture, the surgeon wanted to add a plate to increase stability due to the patient's previous lack of compliance.After choosing the arrow suture plate, the surgeon was unable to lock the screws successfully in the plate.The screws were not sitting flush, which caused the surgeon to abandon use of the plate and rely on the cannulated screws and fibertape he utilized at the beginning of the case.Additional information requested.Additional information provided 8/30/2021: dos is (b)(6) 2021, date of revision is (b)(6) 2021.The patient fell on the operative leg shortly after surgery, thus refracturing her patella which is the reason for the revision.During the revision, the surgery explanted the previously placed 4.0 cannulated screws and fibertape.(ar-5051-30, ar-5051-34, ar-7237-17ln).

• Brand Name: LO-PRO SCRW, CANN, BLUNT TIP, 4 X 34 MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12467755
• MDR Text Key: 271300330
• Report Number: 1220246-2021-03657
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867217584
• UDI-Public: 00888867217584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW, CANN, BLUNT TIP, 4 X 34 MM
• Device Catalogue Number: AR-5051-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other