MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,30MM LGTH; PLATE, FIXATION, BONE

Model Number COMPR FT SCRW,2.5 MICRO,30MM LGTH

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2020

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.

Event Description

It was reported, that during a dip fusion as the surgeon was inserting the ar-8725-30h screw into the drilled tunnel 1/2 of the screw head broke off.The case was completed by leaving the broken screw in the tunnel with half a screw head.

• Brand Name: COMPR FT SCRW,2.5 MICRO,30MM LGTH
• Type of Device: PLATE, FIXATION, BONE
• 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: 11186505
• MDR Text Key: 227486614
• Report Number: 1220246-2021-02484
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867126930
• UDI-Public: 00888867126930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COMPR FT SCRW,2.5 MICRO,30MM LGTH
• Device Catalogue Number: AR-8725-30H
• Device Lot Number: 10334305
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2019
• 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 Outcome(s): Other