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

Catalog Number PIP-200-30P-WW

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 07/03/2014

Event Type  malfunction  

Event Description

It was reported: 'surgeon had broached appropriately with good depth and was able to push and pull the broach without restriction.Placed the impactor in-line with the implant and used a small mallet.Multiple taps with minimal force.Head of implant broke off leaving the stem in-situ.Implant was broken into many pieces and was disposed of on the spot.Broken stem was taken out by piece-meal approach and a replacement implant of the same size was placed without incident.' add'l info was requested by integra.On july 16, 2014 add'l info was rec'd.Advised by customer, no photos of x-rays are available.No intraoperative or/post-operative x-rays were available.The delay in surgery occurred while trying to get the broken stem out.No known adverse consequence to patient.Patient condition to date: good so far.Type of mallet used mono-block, metal mallet (small) as supplied by (b)(4).

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported info.

• Brand Name: PIP SZ. 30 PROXIMAL
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX 78754
• Manufacturer Contact: caren finkelstein ; 315 enterprise; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4030850
• MDR Text Key: 4876324
• Report Number: 1651501-2014-00033
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIP-200-30P-WW
• Device Lot Number: 140889T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• 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
• Treatment: MALLET USED 'MONO-BLOCK, METAL MALLET (SMALL) AS; SUPPLIED BY (B)(4)'