MAUDE Adverse Event Report: ARTHROSURFACE, INC. CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT; TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS

Catalog Number 9159-3045

Device Problem Dull, Blunt (2407)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was returned and the complaint was confirmed.Arthrosurface engineering department inspected and tested the instrument.The reamer did function as intended without any issues.Engineering personnel spoke with the surgeon regarding the results of the testing.A rm of arthrosurface shall attend the future cases of this surgeon.As of submission date, the patient is doing well with no issues.The complaint is considered closed.

Event Description

The event occured during a hemicap mtp df surgery.Surgeon was almost complete.But did not think he was quite deep enough on the metatarsal head.He continued to ream and fractured the metatarsal head.Surgeon asked if the reamer is dull.Arthrosurface has been notified of the issue on the same day of the incident.

• Brand Name: CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
• Type of Device: TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st.; stoughton MA 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5550453
• MDR Text Key: 42640718
• Report Number: 3004154314-2016-00009
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2016

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
• Device Operator: Physician
• Device Catalogue Number: 9159-3045
• Device Lot Number: 75JE1416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other