MAUDE Adverse Event Report: SYNTHES MONUMENT 14MM/130 DEG TI CANN TFNA 440MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.465S

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.Date of device breakage is not known.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 that patient underwent hardware removal due to a titanium (ti) cannulated trochanteric fixation nail advanced (tfna) nail breakage, nonunion, and pain.Patient was implanted with one (1) nail, one (1) tfna screw, and two (2) ti distal locking screws on (b)(6) 2016.The patient presented in the emergency room on or about (b)(6) 2017 complaining of pain.X-rays taken on unknown date revealed a broken nail.Revision surgery was performed on (b)(6) 2017.Fragments generated from the broken nail were removed.Removal of broken nail was difficult and required additional intervention.Procedure was successfully completed without surgical delay.Concomitant devices reported: tfna screw (part 04.038.110s, lot number unknown, quantity 1); ti distal locking screw (part 04.005.540s, lot number unknown, quantity 1); ti distal locking screw (part 04.005.542s, lot number unknown, quantity 1).This report is for one (1) tfna nail.This is report 1 of 1 for com-(b)(4).

• Brand Name: 14MM/130 DEG TI CANN TFNA 440MM/LEFT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 6593775
• MDR Text Key: 76043988
• Report Number: 1719045-2017-10503
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.465S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING SCREW (04.005.540S, LOT UNKNOWN, QTY 1); LOCKING SCREW (04.005.542S, LOT UNKNOWN, QTY 1); TFNA SCREW (04.038.110S, LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention