MAUDE Adverse Event Report: SYNTHES MEZZOVICO END-CAP F/A2FN CANN EXTENS. 5 TAN GREY; NAIL, FIXATION, BONE

Catalog Number 04.009.001S

Device Problem Difficult to Insert (1316)

Patient Problem Sedation (2368)

Event Date 03/19/2014

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis additional narrative: a review of the device history records was performed and no complaint related issues were found.An evaluation was performed on the returned device.As per received condition; the complained end-cap received for investigation shows no damage.The manufacturing and inspection records indicate no problems with the lot in question.There are not any other similar complaints associated to the article and lot number in question.No product related fault was found.To prevent such situations, it is recommended to follow the corresponding product technique guide.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The afn nailing system was used for a fracture of shaft of femur case.The surgeon took time to achieve reduction.Then the surgeon tried to insert the end cap10mm into the nail using the guide wire with normal procedure, the end cap spun free without any resistance, abnormal noise was present and device could not be inserted at all.The surgeon then removed residual materials and opened the surgical incision using the k-wire to make enough space for the end cap to be inserted, he tried to insert it again, but it failed again.The surgeon inserted the rod for extraction by way of trial, it was successful.The surgeon then tried again to insert the end cap 5mm and was not successful.There was a 90 minute surgical delay reported.This is report 2 of 3 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.510k#: device is not distributed in the united states, but is similar to device marketed in the the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records has been requested.

• Brand Name: END-CAP F/A2FN CANN EXTENS. 5 TAN GREY
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3753109
• MDR Text Key: 11977405
• Report Number: 1000562954-2014-10052
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 04.009.001S
• Device Lot Number: 8417912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention