MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL SUTUREPLATE, 3-HOLE, TITANIUM; BONE FIXATION PLATE

Model Number	HUMERAL SUTUREPLATE, 3-HOLE, TITANIUM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an orif proximal humerus surgery the screw ar-14244 got stuck in the humeral plate ar- 14003 (lot number: 15103696).The surgeon had to remove the plate together with the screw and a new plate had to be used.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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 allegation is confirmed.One unpackaged ar-14003 was received for evaluation.The device arrived with a screw stuck in the hole number 7.Visual inspection revealed damage to the center oval hole, scratches on the surface, and discoloration.The diameter of the screw was not measured as the screw is stuck inside the bushing hole.The device bushing holes were rotate to check for any resistance and not issues were found.The most likely cause of the reported failure can be attributed to user error, as damage was observed on the head of the screw, excessive force was used, or there was a misalignment during insertion.

• Brand Name: HUMERAL SUTUREPLATE, 3-HOLE, TITANIUM
• Common Device Name: BONE FIXATION PLATE
• 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: jared engle ; 8009337001
• MDR Report Key: 19237931
• Report Number: 1220246-2024-02747
• Device Sequence Number: 12780443
• Product Code: HRS
• UDI-Device Identifier: 00888867016125
• UDI-Public: 00888867016125
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K041965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: HUMERAL SUTUREPLATE, 3-HOLE, TITANIUM
• Device Catalogue Number: AR-14003
• Device Lot Number: 15103696
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown