MAUDE Adverse Event Report: ARTHREX, INC. OSTEOTOME, ANGLED UP, 5.5 MM; ACCESSORIES, ARTHROSCOPIC

Model Number	OSTEOTOME, ANGLED UP, 5.5 MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/27/2022
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 that during an ankle fusion surgery the end of the device snapped off when preparing the ankle for fusion.The broken off end of the device was stuck in the patients tibia.The surgeon tried to remove the fragment, but came to the conclusion that he would not be able to remove the fragment and so he left it in situ.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Visual inspection found the end of the device was broken off.Complaint was confirmed.

• Brand Name: OSTEOTOME, ANGLED UP, 5.5 MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: 15223853
• Report Number: 1220246-2022-05365
• Device Sequence Number: 14838392
• Product Code: NBH
• UDI-Device Identifier: 00888867044227
• UDI-Public: 00888867044227
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: OSTEOTOME, ANGLED UP, 5.5 MM
• Device Catalogue Number: AR-8650-08
• Device Lot Number: 031749
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown