MAUDE Adverse Event Report: ARTHREX, INC. IM ALIGNMENT GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IM ALIGNMENT GUIDE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2021
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
It was reported while prepping tibial resection the spike on the ar-613-10 broke off.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation, and the pictures provided do not show the entire r-613-10 device.It was not possible to confirm the allegation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per wi-000100100.

• Brand Name: IM ALIGNMENT GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11798853
• Report Number: 1220246-2021-03039
• Device Sequence Number: 1099285
• Product Code: LXH
• UDI-Device Identifier: 00888867115958
• UDI-Public: 00888867115958
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/15/2021

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: IM ALIGNMENT GUIDE
• Device Catalogue Number: AR-613-10
• Device Lot Number: 130631338F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1