MAUDE Adverse Event Report: ARTHROSURFACE, INC. ARTHROSURFACE TOEMOTION; ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT

Model Number 4P09-2000

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

A review of device history record of the suspect lot indicated all parts were built to specification.The reamer in question was reviewed by the engineering department.Slight normal wear and tear from general use of the instrument is visible.The investigation concluded that the reamer is still functional and satisfies the intended purpose.There is no evidence that the reamer had actually contributed to the reported phalangeal fracture.The outcome of a case depends on several factors such as surgeon's operating technique, patient factors like age, bone density, clinical history etc., this is the first complaint of this type and arthrosurface will continue to monitor.

Event Description

A patient's phalangeal bone was fractured while preparing the implant site with an arthrosurface reamer.The surgeon was curious if the reamer was dull.

• Brand Name: ARTHROSURFACE TOEMOTION
• Type of Device: ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT
• 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: 6865167
• MDR Text Key: 86148404
• Report Number: 3004154314-2017-00016
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 4P09-2000
• Device Lot Number: 75HE0708R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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