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

Catalog Number 04.004.455S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient weight is not available for reporting.Date of event is unknown.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(therapy date): unknown.A device history record review was completed for part #04.004.455s, lot # 7989682: manufacturing location: (b)(4), manufacturing date: 04-may-2015, expiration date: 31-mar-2024: no non-conformance reports (ncrs) 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 the patient with a right tibia fracture had im rodding on (b)(6) 2016.The patient experienced an infected nonunion and on (b)(6) 2016 had removal of internal fixation (1 nail and 4 locking screws).The surgeon also removed (1 unknown plate and 5 unknown screws from an old ankle fracture that was healed).The patient had a repeat right tibia im nailing, replating of the tibia/fibula and an antibiotic spacer.The unknown plate and 5 unknown screws were not related to the nonunion or infection.The procedure was successful and patient outcome reported as stable.There was no surgical delay and patient outcome reported as stable.The patient is scheduled for bone grafting in 6 weeks.Concomitant devices reported: plate (part #unknown, lot # unknown, quantity 1), screw (part #unknown, lot # unknown, quantity 5).This is report 1 of 5 for (b)(4).

• Brand Name: 10MM 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6183121
• MDR Text Key: 62671314
• Report Number: 1719045-2016-10922
• 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
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 04.004.455S
• Device Lot Number: 7989682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FIVE (5) UNKNOWN SCREW; ONE (1) UNKNOWN PLATE
• Patient Outcome(s): Required Intervention