MAUDE Adverse Event Report: ARTHROSURFACE, INC. ARTHROSURFACE PHALANGEAL FIXATION COMPONENT; PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Description

Guidewire bent while reaming phalangeal side of 1st mtp joint.Fda safety report id# (b)(4).

• Brand Name: ARTHROSURFACE PHALANGEAL FIXATION COMPONENT
• Type of Device: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
• Manufacturer (Section D): ARTHROSURFACE, INC.
• MDR Report Key: 14015077
• MDR Text Key: 288799700
• Report Number: MW5108762
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1