MAUDE Adverse Event Report: ARTHREX, INC. FOREFOOT INTERNAL BRACE IMPLANT; PROSTHESIS, TOE, HEMI,PHALANGEAL

Model Number AR-1530-CP

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2019

Event Type  Injury  

Event Description

When using the forefoot internal brace implant system, a piece of one of the instruments broke off in the pt's foot.X-ray of the foot was done, the piece was unable to be seen in the foot.Fda safety report id# (b)(4).

• Brand Name: FOREFOOT INTERNAL BRACE IMPLANT
• Type of Device: PROSTHESIS, TOE, HEMI,PHALANGEAL
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 8906408
• MDR Text Key: 154848551
• Report Number: MW5089117
• Device Sequence Number: 1
• Product Code: KWD
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR-1530-CP
• Device Lot Number: 10298681
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR