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

Model Number HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

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 Description

On (b)(6) 2022, it was reported by a arthrex employee via phone that a ar-14005 humeral sutureplates bushings on the plate fell off.This occurred on (b)(6) 2022.During a humeral fracture.All fragments were retrieved, and the case was completed using another plate.There was no patient effect reported.

• Brand Name: HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
• Type of Device: 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: 14074944
• MDR Text Key: 298598193
• Report Number: 1220246-2022-04712
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867016149
• UDI-Public: 00888867016149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUMERAL SUTUREPLATE, 5-HOLE, TITANIUM
• Device Catalogue Number: AR-14005
• Device Lot Number: 10283869
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1