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

Catalog Number PIP-200-20P-WW

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The surgeon was performing a procedure on (b)(6) 2015.The surgeon implanted the proximal component, pip-200-20p-ww, but decided the bone needed a bit more adjustment for the implant to work properly.The surgeon attempted to remove the implant by covering the head of the implant with a lap, since you can't grab the device with anything sharp, and tried to remove the implant with some forceps but the implant head broke on one of the condyles.The surgeon then proceeded to remove the remainder of the implant with the trial extraction tool but the head broke off of the stem.The stem of the implant was then flush with end of the proximal phalange and the surgeon had to bore out the implant with a k wire and then a 2.0 mm drill bit off a zimmer mini frag set that the facility had on hand.A proper extraction tool, one designed for the integra device would have been perfect to prevent this from happening.It was reported that the event occurred during a procedure; however, no pt injury is alleged.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: methods: review of device history records.Review of complaints history.Results: efforts to retrieve the fractured implant were unsuccessful; therefore, a failure analysis could not be performed.Lot# 150247t, date inspected; (b)(6) 2015 no nonconformances were recorded inspection records.The review did not identify nonconformances 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.During this period of time there have been (b)(4) units sold.The resulting rate of complaints is (b)(4) which does not represent an adverse trend.Conclusion: in the past, similar fractures have been attributed to improperly prepared oblique osteotomy, improper placement of the implant (e.G., impacting unsupported head with excessive force), or improper implant size selection.The surgeon suggested the need for an extraction tool designed specifically for this type of implant.This suggestion has been communicated to the product development and marketing departments.A definitive root cause cannot be identified at this time, but the root cause of the fracture is most likely related to the technique used for bone preparation and/or impaction.The lack of adequate instrumentation for pyrocarbon implant removal could be a contributing cause.

• Brand Name: PIP SZ 20 PROXIMAL
• Type of Device: PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; austin TX
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4865060
• MDR Text Key: 5811184
• Report Number: 1651501-2015-00016
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H010005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• 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: 150247T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• 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: 59 YR