MAUDE Adverse Event Report: SYNTHES ELMIRA 1.25MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE,SURGICAL

Catalog Number 292.12

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

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

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age or date of birth, and weight not available for reporting.Additional product code: hty (b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that on (b)(6) 2017 during an original distal radius surgery, the kirschner wire (k-wire) broke into 2 separate pieces while it was being removed.The patient was implanted with the plate and screw.At the end of the procedure the kirschner wire broke while it was being removed independently.The kirschner wire was not interacting with any other device when the malfunction occurred.Fragments were generated and they were removed successfully.No fragments were retained within the patient.The surgery completed successfully without any delay.Patient was reported to be in stable condition.Concomitant devices reported: plate (part number unknown, lot number unknown, quantity unknown); screws (part number unknown, lot number unknown, quantity unknown).This report is for one (1) kirschner wire, this is report 1 of 1 for (b)(4).

• Brand Name: 1.25MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE,SURGICAL
• 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: 6805810
• MDR Text Key: 83121733
• Report Number: 3003506883-2017-10172
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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