MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA THREE HOLE CUBE; INTEGRA EXTERNAL FIXATION SYSTEM

Catalog Number 12224224

Device Problems Fitting Problem (2183); Failure to Align (2522); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Event Description

It was reported the surgeon ran into an issue with two half pins and a three-holed cube.Two different pins would not fit through the proximal hole of a three-holed cube.Dr.(b)(6) first thought it was the technique of the fellow he was teaching then we heard the metal-on-metal grinding sound and the drill stopped.Dr.(b)(6) pulled another pin and tried it himself but the same thing happened.They had already placed a pin through the distal hole of the cube so he didn't pull a new cube; he just left it with one pin.It was reported that although device was in use for this event there was no patient injury.

Manufacturer Narrative

Integra completed its internal investigation 2sep2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: the lot number was not provided and a review of the manufacturing records, inspection and tests result documents could not be performed.Complaint rate: total # complaints = 1.Procedures of the external fixation system = 22 procedures.Complaint rate = 1/22 100 = 4.5%.Note: the ex-fix system is a recently launched product line and currently is under a controlled market release (cmr) and according to marketing only 22 cases have been performed at this time.The complaint rate is determined to be probable (b)(4) and moderate in severity.However, with only 22 procedures having been conducted, no adverse trend could be identified from calculations.Conclusion: possible root cause for this complaint may be a manufacturing issue, application and or design.Needless to say further investigation by product development will be performed to determine root cause and any actions deemed necessary.

Manufacturer Narrative

Integra completed its internal investigation 5oct2016.The investigation included: method: evaluation of actual device.Review of device history records.Review of complaint management database for similar complaints.Results: a review of the manufacturing records, inspection and tests result documents show the parts were to manufactured to specifications complaint rate: total # complaints = (b)(4).Procedures of the external fixation system =(b)(4) procedures.Complaint rate = (b)(4)%.Note: the ex-fix system is a recently launched product line and currently is under a controlled market release (cmr) and according to marketing only (b)(4) cases have been performed at this time.Conclusion: the parts were returned and inspected and found to meet specification (for both the pins and three hole cube).This complaint is indicative of the surgical technique being the sole issue.Metal grinding can be heard and galling can occur if the pins are not aligned properly in the threaded holes of the cube.Improper surgical technique is the root cause of this complaint.

• Brand Name: THREE HOLE CUBE
• Type of Device: INTEGRA EXTERNAL FIXATION SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• 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: 5773092
• MDR Text Key: 49755721
• Report Number: 1651501-2016-00027
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K140463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2016

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: 12224224
• Device Lot Number: PN6469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/13/2016; 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1