MAUDE Adverse Event Report: SYNTHES MONUMENT 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE; NAIL,FIXATION,BONE

Catalog Number 04.034.346S

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement.Udi: (b)(4).Device malfunctioned pre-operatively and was not implanted / explanted.Dhr review for part #04.034.346s lot #7644975.Release to warehouse date: apr 2, 2014.Expiration date: 02/2023.Manufactured by: (b)(4).No ncrs were generated during production; review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Subject device has been received and is currently in the evaluation process.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.

Event Description

It was reported that the outer package of the 9mm tibial nail-ex has the correct item number and description; however, the stickers are green but should be blue.This was discovered during restocking the nail.There was no patient involvement.This report is for one (1) 9mm cannulated tibial nail-ex.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing evaluation was completed.Sealed package was received with green sticker on the label.After reviewing the complaint and reviewing the physical packaged product that was provided, it was determined that the complaint is confirmed.The color code component (sticker), which is the focus of this complaint, is obtained by the operator at operation 110, generate label for sterile nails.It appears that the operator who performed op 110 did not check and confirm that the sticker was the correct color.(there are several such components (stickers) located in the cell, which are on reels, and these reels are physically located next to each other.It is believed that the operator took the incorrect color sticker at that time.) the two operations where the operator is supposed to confirm the color of the component (sticker) are op 110 and op 130.Neither operator discovered that the sticker was the wrong color.Based on examining the carton, and reviewing the complaint, the cause of the component (sticker) being the wrong color was due to the operator for op 110 using the wrong color sticker.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: 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6779231
• MDR Text Key: 83014524
• Report Number: 1719045-2017-10750
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040762
• 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,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 04.034.346S
• Device Lot Number: 7644975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1