MAUDE Adverse Event Report: ARTHREX, INC. IMPACTOR PAD; INTRAMED FIXATN ROD AND ACCESS

Model Number	IMPACTOR PAD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2023
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
On (b)(6) 2023, it was reported by a sales representative via email that a 0837-000 impactor pad broke.This was discovered during a procedure on a.(b)(6) 2023.Additional information requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged 0837-000 serial/batch number 130029 was received for evaluation.Visual inspection revealed that the threaded connector was broken off.Functional testing cannot be performed as the device was broken.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: IMPACTOR PAD
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 17710266
• Report Number: 1220246-2023-07822
• Device Sequence Number: 14012256
• Product Code: HSB
• UDI-Device Identifier: 00848665013559
• UDI-Public: 00848665013559
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: IMPACTOR PAD
• Device Catalogue Number: 0837-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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