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	08/21/2023
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 08/21/2023, it was reported by a sales representative via sems that a 0826-000 impactor rod is broken.This occurred during a case.There was no additional information provided, additional information has been requested.
Additional Manufacturer Narrative
The complaint was confirmed.One unpackaged 0826-000 serial/batch number (b)(6) was received for investigation.Functional testing was not conducted due to the damage to the instrument.Visual evaluation found that the connector thread was broken off.The most likely cause for the reported failure is a user error.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.

• 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: 17745981
• Report Number: 1220246-2023-07902
• Device Sequence Number: 19855060
• Product Code: HSB
• UDI-Device Identifier: 00848665002805
• UDI-Public: 00848665002805
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 11/07/2024

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: 0826-000
• Device Lot Number: 180335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/07/2024
• 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