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

Catalog Number 292.12

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Additional information: patient initials: (b)(6), added adverse event, describe event or problem, event problem codes.Additional product code: hty.Other: udi: (b)(4) lot unknown.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.Reported on user facility medwatch: pt info, adverse event or product problem: product problem, outcomes attributed to adverse event, date of event, describe event or problem: initial complaint description, relevant tests/lab data, other relevant history, catalog number, is this a single-use device that was reprocessed and used on a pt? correct information from the user facility medwatch: suspect medical device.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

This report is against (b)(4).The only information contained in this report is correction or additional information.There were no issues with any of the other implants or instruments.The patient's outcome is stable and there were no surgical delays.Concomitant devices: plate (part and lot unknown, quantity 1); cortex screw (part 202.874, lot unknown, quantity 1); locking screw (part 212.818, lot unknown, quantity 1).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 USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5937046
• MDR Text Key: 54272353
• Report Number: 2520274-2016-14468
• Device Sequence Number: 1
• Product Code: LRN
• 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
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CORTEX SCREW (202.874); LOCKING SCREW (212.818); UNKNOWN PLATE