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 Problems Break (1069); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 07/18/2019

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 during a revision screw removal procedure, as the surgeon was coring out the bone around the implanted 2. 5 headless compression screw, the head of the screw broke off and became stuck inside of the ar-8737-59 screw extractor/trephine. The screw broke off flush below the cortex, and the body of the screw was left implanted in the bone. The rep stated the primary procedure took place approximately 2-3 years ago. The reason for the revision was due to the screw protruding 2-3mm out of the bone. The protruding screw was causing pain and discomfort for the patient. The primary procedure was performed by a different surgeon. The rep confirmed the ar-8737-59 and broken screw head will be returning for evaluation. The rep stated they currently do not have any additional details regarding the primary procedure. Additional information received on 07/30/2019: the rep stated the primary procedure was a mtp fusion procedure, and the part and lot numbers of arthrex devices implanted during the primary procedure are unknown. The rep reported the part and lot number of the 2. 5 headless compression screw that the surgeon was attempting to explant during the revision procedure is unknown. It is unknown when the implanted screw was discovered protruding. The rep reported there were not any other arthrex devices explanted during the revision procedure. There are not any de-identified copies of x-rays available. Additional information received on 09/05/2019: the rep reported the part number of the screw that the surgeon was attempting to remove during the revision procedure was ar-8725-30h, 2. 5 x 30mm headless screw (lot unknown). The original procedure was an orif rt first met and took place on (b)(6) 2015. The pre-op diagnosis was rt first met fx.

• 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: 9119561
• MDR Text Key: 163123427
• Report Number: 1220246-2019-01331
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: COMPR FT SCRW,2.5 MICRO,30MM LGTH
• Device Catalogue Number: AR-8725-30H
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/25/2019 Patient Sequence Number: 1