MAUDE Adverse Event Report: SYNTHES MEZZOVICO 11MM TI CANNULATED TIBIAL NAIL-EX/405MM; NAIL, FIXATION, BONE

Catalog Number 04.004.561

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth and weight are not available for reporting.Device was not implanted or explanted.Event occurred during procedure.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device history records review was completed for part # 04.004.561, lot # 8693009.Manufacturing location: (b)(4), manufacturing date: oct 28, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 as follow: it was reported that on (b)(6) 2016, during the initial surgery, the doctor could not deploy the nail into the patient, due to wear apparent at the top and the bottom of the nail.Damaged interior and the presence of slots.The surgery was delayed for 15 minutes.This complaint involves one (1) part.Concomitant parts reported: screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) tibial nail.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/405MM
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6054873
• MDR Text Key: 58305769
• Report Number: 1000562954-2016-10198
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040762
• 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
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.004.561
• Device Lot Number: 8693009
• Other Device ID Number: (01)07611819171367(10)8693009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREW, UNKNOWN QUANTITY