MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW, 5.0 LG, 42MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW, 5.0 LG, 42MM LGTH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that an ar-8750-46h, an ar-8750-42h, and an ar-8750-38h had issues.During a fulkerson osteotomy procedure on 06/03/2022, all three complaint devices were implanted, and the case was completed successfully with no impact to the patient.On (b)(6) 2022, the x-ray was showing that 2 of 3 screws were bending.On (b)(6) 2022, on the next x-ray, 2 of the 3 screws were broken inside the patient post-op.According to the x-ray and the sales representative, it was assumed that the ar-8750-46h and ar-8750-42h were broken.The broken screws were securely affixed inside the patient, and the surgeon was not planning a revision surgery and deemed it safe to leave the broken screws inside the patient, but just wanted to have the complaint reported.The patient is fine to date.On (b)(6) 2022, another sales representative called and provided via phone the following information: on (b)(6) 2022, a revision surgery was performed by the same surgeon to remove the broken ar-8750-46h and ar-8750-42h from the patient successfully.Both complaint devices were available for return.
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
Complaint confirmed.Upon visual inspection, it was noted that the device was broken.Measurements were unable to be taken due to the broken state of the device.The cause of this remains undetermined.

• Brand Name: COMPR FT SCRW, 5.0 LG, 42MM 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: 15484141
• Report Number: 1220246-2022-05520
• Device Sequence Number: 19331686
• Product Code: HRS
• UDI-Device Identifier: 00888867262928
• UDI-Public: 00888867262928
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW, 5.0 LG, 42MM LGTH
• Device Catalogue Number: AR-8750-42H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown