MAUDE Adverse Event Report: SYNTHES MONUMENT 9MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.355S

Device Problem Difficult To Position (1467)

Patient Problem Sedation (2368)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: monument.Manufacturing date: january 22, 2015.Expiration date: december 31, 2023.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.Sterility documentation was reviewed and determined to be conforming.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an open reduction internal fixation (orif) of a left tibia on (b)(6) 2016, when attempting to disengage the connecting screw from the nail the surgeon met resistance.After a delay of fifteen (15) minutes, the surgeon removed all screws and backed out the nail.The connecting screw finally released from the nail, but it was noticed the top of the nail was broken at the head.Another length nail was attempted, two proximal screws were inserted and attempted to disengage the same connecting screw once more and met resistance a second time.The surgeon removed all screws and removed the connecting screw completely.The surgeon decided to utilize a non-synthes device instead.There was a thirty to forty-five (30-45) minute surgical delay due to the issue with the connection screw.It was also reported that during this procedure when the surgeon was putting the drill bit through the trocar the surgeon met resistance with the nails.There is a concern that the aiming arm may not be calibrated correctly.The construct was assembled properly.Because the connecting screw was not functioning properly this may have contributed to the misalignment of the devices.This is report 2 of 7 for (b)(4).

• Brand Name: 9MM TI CANNULATED TIBIAL NAIL-EX/375MM-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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5409907
• MDR Text Key: 37445480
• Report Number: 1719045-2016-10109
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040762
• 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
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 04.004.355S
• Device Lot Number: 7894016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR