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

Model Number BASEPLATE IMPACTOR, ASSEMBLY

Device Problems Break (1069); Defective Component (2292)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that the blue attachment is defective, it broke off during shoulder prothesis surgery.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

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.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-9165cdg was received for investigation.Visual inspection identified that the post across the face of the baseplate had partially broken.No fragments were returned for inspection.A probable cause is attributed to damage incurred during the removal process.

• 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: 14548110
• MDR Text Key: 300780135
• Report Number: 1220246-2022-04998
• 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,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1