MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ. 20 PROXIMAL

Catalog Number PIP-200-20P-WW

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was reported during surgery, the head of the flat distal implant broke off while trying to remove it from the patient.The surgeon felt the trail(s) and implant were not the same size, and could not get the final (implant) in all the way (it was 3mm short).The surgeon attempted to remove the implant with the extractor from the tray when the implant broke.The extractor that was used was intended for the removal of trial(s) and has pointed metal tips.The surgery time was increased by 10 minutes due to this issue.The surgery was completed and there were no adverse consequences or injury reported.

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: PIP SZ. 20 PROXIMAL
• Type of Device: PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3915269
• MDR Text Key: 4580627
• Report Number: 1651501-2014-00027
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIP-200-20P-WW
• Device Lot Number: 132783T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1