MAUDE Adverse Event Report: ARTHREX, INC. OPENING JACK FRONT ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OPENING JACK FRONT ARM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is an initial report to resubmit all prior information that was submitted through arthrex submission the initial reports dropped from the fda system and therefore blocked the full processing of a follow up submission.After several months of investigation with the fda, due to computer system changes at arthrex as well as the fda, the fda has agreed that arthrex should resubmit a new report to encompass the initial prior 2017 arthrex submissions involved.This report is in reference to: 1220246-2017-00246 (arthrex reference (b)(4) / line 197407).Complaint confirmed.The evaluation revealed slightly bent jack paddles, discoloration on the laser marking and scratches and indentations present on the surface which indicates the devices have been used reprocessed.Prying/leveraging is the normal use of this device and is expected to bend with repeated use.Complaint confirmed.The evaluation revealed slightly bent jack paddles, discoloration on the laser marking and scratches and indentations present on the surface which indicates the devices have been used reprocessed.Prying/leveraging is the normal use of this device and is expected to bend with repeated use.
Event or Problem Description
This is an initial report to resubmit all prior information that was submitted through arthrex submission the initial reports dropped from the fda system and therefore blocked the full processing of a follow up submission.After several months of investigation with the fda, due to computer system changes at arthrex as well as the fda, the fda has agreed that arthrex should resubmit a new report to encompass the initial prior 2017 arthrex submissions involved.This report is in reference to: 1220246-2017-00246 (arthrex reference (b)(4)/ line 197407).The following is the previously reported information mentioned above: it was originally reported, a loaner set was used for the procedure.The teeth on the jack arms began to bend as the osteotomy site was jacked open.Eventually the arms would not stay in place due to the teeth bending.They tried to bend the teeth back in order to use the instrument and insert the implant, however it wouldn¿t stay in place.The measurement guide was also inaccurate due to the bent teeth.The two parts of the opening jack were: ar-13430-01, opening jack back arm.Ar-13430-01 ((b)(4) line 197397) and ar-13430-02, opening jack front arm, ar-13430-02 ((b)(4) line 197407).The surgeon had to change plans and went with a contourlock plate after trying several other instruments to hold the osteotomy open and eventually fracturing the tibial plateau.The quality of the bone was reported to be fair.Case: proximal tibial osteotomy.Patient: male additional information received 6/27/2017: the fractured tibial plateau reduced itself when pressure was released.The surgeon has no plans to do anything further surgically due to the incident.The contour lock plate that was used was an ar-13730-02 lot number 1264409.

• Brand Name: OPENING JACK FRONT ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10774452
• Report Number: 1220246-2020-02299
• Device Sequence Number: 3645559
• Product Code: LXH
• UDI-Device Identifier: 00888867012912
• UDI-Public: 00888867012912
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: OPENING JACK FRONT ARM
• Device Catalogue Number: AR-13430-02
• Device Lot Number: 221707
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other