MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PIP SZ. 30 PROXIMAL

Catalog Number PIP-200-30P-WW

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported the pip implant shattered during surgery.On (b)(6) 2014 additional information was received from the distributor's quality and regulatory assurance officer.The implant snapped whilst being implanted.Surgery time was increased by 15 minutes due to this issue.The surgeon used a spare device, which was available, to complete the surgery.There was no injury or adverse consequence alleged.Additional information was requested numerous times by integra.

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. 30 PROXIMAL
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3897127
• MDR Text Key: 4648654
• Report Number: 1651501-2014-00026
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: PIP-200-30P-WW
• Device Lot Number: 10-2878
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• 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