MAUDE Adverse Event Report: SYNTHES ELMIRA 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM; PIN, FIXATION, SMOOTH

Catalog Number 292.20

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.This part number is for one, ten pack of kirschner wire w/trocar point 150mm.Three (3) of these wires reportedly broke resulting in fragmentation.The reported devices were used for demonstration purposes only.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: feb 27, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a demonstration on (b)(6) 2017, the blade on a pair of pliers chipped and three (3) 2.0mm kirschner wires broke in two (2) pieces instead of bending.The wires broke at the tips.There was no procedural or patient involvement.This report is for three (3) 2.0mm kirschner wires.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional device product code use lrn.Product development investigation has been completed for part# 292.20, lot# 7927158.A visual inspection, device history records (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.The 292.20 lot number 7927158 2.0mm kirschner wire ten pack was returned and reported that three wires had broken into two pieces.This condition is confirmed; three of the returned k-wires show significant deformation at the end and measure several millimeters shorter than their intact counterparts.It is likely that the application of excessive force during surgery or possibly repeated use over its two year lifespan has led to this complaint condition.The wires were manufactured in 2/2015 and are over two years old.The balance of each of the returned wires is in otherwise usable condition.Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6327901
• MDR Text Key: 67340922
• Report Number: 3003506883-2017-10017
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 20886982180411
• UDI-Public: (01)20886982180411(10)7927158
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.20
• Device Lot Number: 7927158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1