MAUDE Adverse Event Report: ARTHREX, INC. SUPRAPATELLAR INSERTION GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	SUPRAPATELLAR INSERTION GUIDE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2021
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) 2021, it was reported by a sales representative via sems that an 1239-100 locking knob cross-threaded into an 1255-300 suprapatellar guide.This was discovered during a tibial nail procedure.Surgeon could not complete case due to the devices getting stuck.About an hour or so after the case, sales representative was finally able to remove the knob from the guide but they were both unsalvageable due to the cross-threading.
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) 2021, it was reported by a sales representative via sems that an 1239-100 locking knob cross-threaded into an 1255-300 suprapatellar guide.This was discovered during a tibial nail procedure.Surgeon could not complete case due to the devices getting stuck.About an hour or so after the case, sales representative was finally able to remove the knob from the guide but they were both unsalvageable due to the cross-threading.

• Brand Name: SUPRAPATELLAR INSERTION GUIDE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 13054589
• Report Number: 1220246-2021-04148
• Device Sequence Number: 20069917
• Product Code: HSB
• UDI-Device Identifier: 00848665039153
• UDI-Public: 00848665039153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/21/2021

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: SUPRAPATELLAR INSERTION GUIDE
• Device Catalogue Number: 1255-300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown