MAUDE Adverse Event Report: SYNTHES MEZZOVICO 10MM TI CANNULATED TIBIAL NAIL-EX/375MM; NAIL, FIXATION, BONE

Catalog Number 04.004.455

Device Problems Sticking (1597); Separation Failure (2547)

Patient Problem Sedation (2368)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

Device was not implanted or explanted during the surgical procedure.An alternate nail was used.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: january 31, 2013.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a connection screw could not be separated from an insertion handle during a surgical procedure on (b)(6) 2015.Per the reporter, several attempts were made with all of the appropriate instruments, but the devices could not be separated from one another.It was necessary for the surgeon to remove the nail and replace it with another.The procedure was prolonged by sixty (60) minutes or more.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device.The subject device was returned along with the complained insertion handle and connecting screw.The subject nail was received with a part of the positioning groove in the top part of the nail expanded.This damage could occur during implant or removal of the nail due to lateral movements.The threads of the nail show some wear marks.A functional test of the received articles showed that the devices could be mounted together without any problems.The complaint issue could not be replicated.Unfortunately without more information or x-rays we are not able to determine the root cause which has led to this complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/375MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5180106
• MDR Text Key: 29323404
• Report Number: 1000562954-2015-10194
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.004.455
• Device Lot Number: 8278848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR