MAUDE Adverse Event Report: SYNTHES (USA) 12MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.242S

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

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.(b)(4).Implant date was provided as (b)(6) 2016.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.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 patient underwent a revision procedure on (b)(6), 2016 for a refracture just below the implanted tfn-advanced proximal femoral nailing system (tfna) nail.Surgeon removed one (1) 12 mm/130 deg titanium cannulated tfna 170 mm - sterile short nail, one (1) tfna screw 95 mm - sterile, and one (1) 5.0 mm ti locking screws w/t25 stardrive recess for im nails/sterile easily with no fragments generated.He then implanted a long tfna nail, lag screw and two distal screws.Routine intraoperative x-rays were taken.There was no surgical delay and no patient harm.The procedure was completed successfully.The patient was implanted with the hardware in (b)(6) 2016 by a different surgeon.The femoral fracture/delayed union occurred on an unknown date.This is report number 2 of 3 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6197941
• MDR Text Key: 63070122
• Report Number: 2520274-2016-15742
• 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: 12/01/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.242S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/22/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR