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

Model Number OSTEOTOME, ANGLED UP, 5.5 MM

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/27/2022

Event Type  malfunction  

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 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.

Manufacturer Narrative

Visual inspection found the end of the device was broken off.Complaint was confirmed.

• Brand Name: OSTEOTOME, ANGLED UP, 5.5 MM
• Type of Device: 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
• MDR Text Key: 305068810
• Report Number: 1220246-2022-05365
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867044227
• UDI-Public: 00888867044227
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1