MAUDE Adverse Event Report: ARTHREX, INC. ANTEGRADE TARGETING MODULE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number ANTEGRADE TARGETING MODULE

Device Problems Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported on 08/24/2022 by a sales representative via email that a 1271-200 targeting module was misaligned and when the 3.2 pin was inserted, broke off inside the patient.This was discovered during a case and broke inside the joint space.Per facility: the surgeon inserted a right antegrade femoral nail size 13x38.The jig was setup properly for a right nail, all connections were tight and the correct side and size nail was loaded onto the jig.After insertion, the surgeon went to throw a 3.2 pin for his distal reconstruction screw using the sheath and the black guide for the 3.2 pin inserted into the sheath.The pin was not properly lined up with the distal reconstruction hole in the nail and instead it was hitting the nail.We then switched the inner sheath out for the correct one for the 5.5 solid drill and attempted to drill into the distal reconstruction hole, again, the jig did not have him lined up and he was hitting the nail.We went back to attempting the 3.2 pin when the tip of the pin broke off in the patient.The surgeon then began attempting to remove the nail by pulling back on the jig when the metal tip inside the jig where the nail attaches broke off from the jig with the locking bolt still inside it and threaded into the nail.The carbon fiber ring surrounding that metal ring that broke off was cracked.The jig was not struck anywhere during insertion, only the impactor pad was malleted.We then used the extractor bolt to remove the nail and had to fish out the piece of 3.2 pin from the patient.A competitive nail was then inserted in place of ours.

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.

• Brand Name: ANTEGRADE TARGETING MODULE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15484452
• MDR Text Key: 301038241
• Report Number: 1220246-2022-05515
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANTEGRADE TARGETING MODULE
• Device Catalogue Number: 1271-200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1