MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,50MM LGTH, STRL; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,50MM LGTH, STRL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during surgery two screws broke.One on implantation an the other by hand.No harm or adverse event for patient, operator or third party was reported.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Update 16-feb-2021: a part of one screw did break off inside the patient but the surgeon was able to remove it and replaced with 2 - 2.5 x 48mm comp ft screws.The other broke outside of the patient with bare hands.The one that broke outside the patient is available for inspection.The surgery was finished successfully with a new device with the same part number.
Additional Manufacturer Narrative
Complaint confirmed, both screws returned were found to be broken.Relevant critical dimensions and the devices material were found to meet drawing specifications.The cause of the event is undetermined, however a likely cause is prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Complaint confirmed, both screws returned were found to be broken.Relevant critical dimensions and the devices material were found to meet drawing specifications.The cause of the event is undetermined, however a likely cause is prying/leveraging the device during insertion.

• Brand Name: COMPR FT SCRW,2.5 MICRO,50MM LGTH, STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11393014
• Report Number: 1220246-2021-02633
• Device Sequence Number: 3117652
• Product Code: HRS
• UDI-Device Identifier: 00888867303959
• UDI-Public: 00888867303959
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: COMPR FT SCRW,2.5 MICRO,50MM LGTH, STRL
• Device Catalogue Number: AR-8725-50HS
• Device Lot Number: 10350826
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 02/11/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 07/07/2021; 08/02/2021
• Patient Sequence Number: 1