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

Catalog Number PIP-200-20P-WW

Device Problem Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Event Description

It was reported the surgeon was impacting the implant with minimal force and the implant broke.A second implant was taken out of the box and the same thing happened.Surgeon then had to go to a bigger size because we had no other 20ps available which added on another 1.5 hours to the case.The surgeon is a new, 1st time user of the product.It was reported the patient was not injured.

Manufacturer Narrative

Integra has completed their internal investigation on 23 oct 2015.The investigation activities included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: device history record reviewed.The review did not identify a nonconformance related to the complaint.A review of complaints for pip implant fractures (both intra-op and post-op) during the last 5 years showed (b)(4) complaints.(b)(4).Conclusion: the cause of the failure has been identified as resulting from impacting the unsupported head when the stem of the implant has not been fully inserted into the medullar canal due to an improperly prepared oblique osteotomy.

• Brand Name: PIP SZ. 20 PROXIMAL
• Type of Device: PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5074646
• MDR Text Key: 26490008
• Report Number: 1651501-2015-00033
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• 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: 132886T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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