MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM; BONE FIXATION PLATE

Model Number	HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2024
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a proximal humeral fracture the variable locking bushing broke out of the plate.The broken piece was retrieved out of the patient.There was no harm for patient, operator or third party reported.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 complaint allegation was confirmed.One unpackaged ar-14005 batch 15129755 was received for investigation.During functional testing, moving the bushing revealed no resistance.During the visual inspection, it was observed that the bushing intended for the central hole was absent.The most probable causes for the reported failure may include user error, inadequate bone preparation, misaligned insertion, or excessive force applied to the fixation screws.

• Brand Name: HUMERAL SUTUREPLATE, 5-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: emily shafer ; 8009337001
• MDR Report Key: 18624872
• Report Number: 1220246-2024-00682
• Device Sequence Number: 7416760
• Product Code: HRS
• UDI-Device Identifier: 00888867016149
• UDI-Public: 00888867016149
• 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): 08/26/2024

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, 5-HOLE, TITANIUM
• Device Catalogue Number: AR-14005
• Device Lot Number: 15129755
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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