MAUDE Adverse Event Report: SYNTHES USA; WIRE,SURGICAL

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Medwatch uf# (b)(4) was originally reported on 5/27/2016.Other therapies in use on patient: not known.Other devices in use on the patient: unknown.This report is for one (1) unknown k-wire.Udi#: unknown part number, udi is unavailable.Device is an instrument and is not implanted/explanted.This report is for one (1) unknown k-wire.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medwatch uf# (b)(4): it was reported that the patient was in the operating room for an epicondyle fracture repair of the right elbow.The intended procedure was for an elbow pinning.While the surgeon was inserting a k-wire in the fracture site, the tip of the k-wire broke off in the patient's humerus.The surgeon was using the synthes 4.0 cannulated screw set and one of the k-wires that comes with it.The surgeon left the tip of the k-wire in the patient's epicondyle in the cortex of the bone.He felt it was too small so then used a synthes 4.5 cannulated screw set and a k-wire from that tray to fixate the fracture.There was no identifying information, device or packaging information available.This report is for one (1) unknown k-wire.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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

Additional information reported: patient was discharged home the same day of the procedure with no noted complications, no delay in operating room time was reported and no reoperation was needed as result of this event.Surgeon proceeded to use 4.5mm screw with a larger k-wire to complete the surgery.

• 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: 5878756
• MDR Text Key: 52201300
• Report Number: 2520274-2016-14109
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR