MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,30MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,30MM LGTH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery during insertion the screw broke off inside the patient.The broken pieces were retrieved from patient.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-8730-30h was received for investigation.No functional testing was performed because the received device was broken into three pieces.Upon visual evaluation, it was noted that the mini compression screw was broken into three pieces.One piece of the screw was damaged entirely, losing the thread geometry.No measurement was possible due to this event.Per drawing finish: anodize teal.It was noted that one out of the three returned pieces did not match the anodize color.The cause remains undetermined.

• Brand Name: COMPR FT SCRW,3.5 MINI,30MM LGTH
• Common Device Name: 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: 16385078
• Report Number: 1220246-2023-06287
• Device Sequence Number: 14831507
• Product Code: HRS
• UDI-Device Identifier: 00888867127043
• UDI-Public: 00888867127043
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW,3.5 MINI,30MM LGTH
• Device Catalogue Number: AR-8730-30H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown