MAUDE Adverse Event Report: ARTHREX, INC. IMPACTOR PAD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	IMPACTOR PAD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the device broke off from the mating instrument.The cause is undetermined, however a likely cause is user-applied mechanical forces.
Event or Problem Description
It was reported by the sales rep that the 0826-000 broke during a procedure.No additional information provided.Further information requested.Additional information provided 6/9/21: procedure being performed was retrograde femoral nail for a distal femoral fracture.The device broke when the surgeon was malleting it lightly upon insertion of the nail.The device was removed and the case was completed by using a longer impactor cap that come in the magellan tray.

• Brand Name: IMPACTOR PAD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12615201
• Report Number: 1220246-2021-03769
• Device Sequence Number: 14446321
• Product Code: HSB
• UDI-Device Identifier: 00848665002805
• UDI-Public: 00848665002805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/12/2021

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: 140219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1