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

Catalog Number PIP-200-20P-WW

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

It was reported during the implantation of the pyrocarbon pip implant in the pt's right hand third finger, the implant shattered or fractured.There was no reported injury or adverse consequence to the pt.The surgery time was increased by 30 minutes.The surgeon replaced the fractured implant with another one with no problems during the second implantation.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: PIP SZ. 20 PROXIMAL
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4152334
• MDR Text Key: 4928763
• Report Number: 1651501-2014-00047
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2014

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: Health Professional
• Device Catalogue Number: PIP-200-20P-WW
• Device Lot Number: 140764T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/03/2014
• 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
• Patient Age: 68 YR