MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. APEX; BONE SCREW

Catalog Number	121-50320
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The joint was exposed and used x- ray to determine the size.It was felt that the patient had plenty of bone space for the large x-post at 20mm in length.The guide wire was placed and then re positioned to get it centered down the canal.The reamer was used and the surgeon said he sunk the black line 2-3mm below the bone surface.It was suggested that if this was hard bone then he should drill, but the dr.Felt it was not necessary.The x-post was implanted and became stuck 3/4 of the way in and would not move.Dr.Provided more force which snapped the end of the screw driver off and left in the post.Dr.Had to fish the head of the screwdriver out.Once this was managed, he tried to take out the post with the other screwdriver.However, due to the force required to remove the post, the cannulated screwdriver snapped again.He tried to locate another 2mm hex screwdriver, however there was no spare available.He tried to use the exposed post window to lever the post out, but this unfortunately snapped the head of the post off.Dr.Was then forced to partially split the bone in order to release the rest of the x post.

• Brand Name: APEX
• Common Device Name: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany
• Manufacturer Contact: brian smekal ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07054 ; 9735888988
• MDR Report Key: 17995358
• Report Number: 3007289093-2023-00015
• Device Sequence Number: 5945825
• Product Code: HWC
• UDI-Device Identifier: 00842078108987
• UDI-Public: 00842078108987
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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 Catalogue Number: 121-50320
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male