MAUDE Adverse Event Report: SYNTHES USA 2.0MM THREADED GUIDE WIRE 230MM; WIRE,SURGICAL

Catalog Number 292.65

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6) date of event: unknown.Additional product code: jdw device is an instrument and is not implanted/explanted.Other): (b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4) pre-amendment.Subject device has not been received.Without a lot number, the device history record review and 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

It was reported that a patient had bilateral femoral osteotomies with pediatric lcp hip plate 27mm.At the end of the procedure she was removing the final 2.0 threaded guide wire on the right femur and it became incarcerated in the plate, and neck and head of the femur.Upon trying to extract the wire it broke off right at the plate.She decided not to remove it and stated it would just provide extra fixation for the time being and that it would be removed when she takes the plates out at a later date.Approximately 30mm remained inside the patient.Surgery was completed successfully with no delays.This complaint involves 1 device this report is 1 of 1 for (b)(4).

• Brand Name: 2.0MM THREADED GUIDE WIRE 230MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5634772
• MDR Text Key: 44516343
• Report Number: 2520274-2016-12562
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMENT
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 2 YR
• Patient Weight: 10