MAUDE Adverse Event Report: SYNTHES ELMIRA 2.8MM GUIDE WIRE WITH FLUTES 450MM; PIN, FIXATION, SMOOTH

Catalog Number 02.207.001

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 07/07/2015

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: during the milling of the femur neck in order to insert the cannulated screw, the guide wire broke inside the head of femur of the patient.It was noted that there were three guide-wires in the instrument; all three were damaged.Two were completely unusable because they were too bent and were not used in the procedure.The one that was used during surgery did not appear to be bent, but it had signs of previous use.The procedure was completed changing the procedure plan and there were inserted two guide wires that will be removed later instead of cannulated screw.The broken guide wire remained inside the patient.There was a delay of surgery reported 20-30 minutes.The patient has a broken wire in the femur head, which the surgeon was unable to retrieve and there is concern regarding the potential risk of migration around the joint / femur head epiphysiolysis.There were three (3) wires: two (2) were delivered already bent and were not used.The third wire was not new, and was likely bent during the insertion in the neck and in the head of the patient.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Device broke intra-operatively.Material is still in hospital.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ the 2.8mm guide wire with flutes, 450 mm, p/n 02.207.001, lot # 6629689, was manufactured to the (b)(4) work order.The first operation was initiated on march 22, 2011 and the last operation, release to warehouse is dated april 19, 2011.The lot was processed per specification requirements and was inspected / conformed to the synthes inspect and final inspection.There were no mrrs, ncrs, or complaint-related issues associated with this lot.(b)(4) parts were released to the warehouse on april 19, 2011.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.

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.

• Brand Name: 2.8MM GUIDE WIRE WITH FLUTES 450MM
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4973568
• MDR Text Key: 6325899
• Report Number: 1719045-2015-10495
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.207.001
• Device Lot Number: 6629689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR