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

Catalog Number	142-45035
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon broke the medial cortical wall when advancing the screw for a small female patient and had to bail out with a longer 4.0 headless screw.The surgeon used the reamers, but not did not use the tap.The ap and lateral views looked ok for the guide wire and reamer.It looked like the correct diameter for the patient (4.5mm), but his first k-wire was out of the medullary canal medially and the screw just followed the same path.The surgeon said he was "fighting the patient's foot proximally".The rep indicated that the surgeon didn't have the "real estate" to bring his hands more medially.
Additional Manufacturer Narrative
Although no death or serious injury was reported, the broken bone could lead to a serious injury.

• Brand Name: JONES UNION
• Common Device Name: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; building a, 2nd floor; parsippany NJ 07054
• Manufacturer Contact: mary hoffman ; 300 interpace parkway; building a, 2nd floor; parsippany, NJ 07504 ; 9735888980
• MDR Report Key: 20750646
• Report Number: 3007289093-2024-00013
• Device Sequence Number: 18176977
• Product Code: HWC
• UDI-Device Identifier: 00842078115329
• UDI-Public: (01)00842078115329
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K081934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 142-45035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown