MAUDE Adverse Event Report: ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number BASEPLATE IMPACTOR, ASSEMBLY

Device Problem Connection Problem (2900)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint confirmed, one of the two circular tabs broke off at the distal end.The proximal end is also worn due to impaction.A likely cause of the broken tab is user-applied mechanical forces.

Event Description

It was reported that during a univers reverse prosthesis surgery the blue plastic part of the device came off.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 05-nov-2021: it was confirmed that the blue part got loose and fell off and didn`t break off.Update avoe 10-jan-2022: the evaluation of the returned device on the (b)(6) 2021 showed that the blue part did not come off but the tabs of the device broke-off.On the (b)(6) 2022 it was confirmed that the broken off tabs did not result during the shipment to inc, but this was what the customer meant with defective.

• Brand Name: BASEPLATE IMPACTOR, ASSEMBLY
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13334019
• MDR Text Key: 288632503
• Report Number: 1220246-2022-04333
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867136731
• UDI-Public: 00888867136731
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BASEPLATE IMPACTOR, ASSEMBLY
• Device Catalogue Number: AR-9165CDG
• Device Lot Number: 051908
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1