MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PROXIMAL PHALANX SURFACE REAMER SZ.10/20; MOVEMENT GREAT TOE

Catalog Number PSR-890-10/20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

This is second report of two reports concerning the same pt surgery.(see mfg report number 1651501-2014-00009).This report concerns the proximal phalanx surface reamer sz.10/20 (psr-890-10/20).It was reported the surgeon used the movement set for a total metatarsal phalangeal joint (mpj) placement.The surgeon had difficulty with the metatarsal reamer 30/40 size and with the phalanx reamer 10/20.The devices seemed dull and they did not ream the bone.Back up reamers was not available.The surgeon used a burr to complete the surgery.The surgery time was extended 45 minutes.There was no injury to the pt alleged.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: PROXIMAL PHALANX SURFACE REAMER SZ.10/20
• Type of Device: MOVEMENT GREAT TOE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3770731
• MDR Text Key: 4359645
• Report Number: 1651501-2014-00010
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PSR-890-10/20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR