MAUDE Adverse Event Report: SYNTHES USA 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.280

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is unavailable.Date of event is unknown.Additional product codes: hrs, hwc.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 a patient underwent an open reduction internal fixation (orif) for a periprosthetic fracture (left distal femur fracture) on (b)(6) 2016.Patient was implanted with a variable angle condylar plate, stainless steel, left, 10 hole and 5.0mm variable angle locking screws.Patient had a clinical visit on an unknown date and reported feeling good with the ability to move the knee.X-rays showed that two of the 5.0mm variable angle locking screws were backing out distally.Patient had revision surgery on (b)(6) 2016 to remove and replace the two screws.It was noted that the locking head of the two screws had become loose from the plate and backed out one cm, not providing a fixed angle construct for the patient.The two screws that were backing out were removed and five screws were added distally.The screws were easily removed without surgical delay or medical intervention.The original plate and original remaining screws were left intact in the patient.Routine x-rays standard for the procedure were taken.The plate did not appear to be stripped, as the surgeon was able to lock the five additional screws into the plate.The procedure was completed successfully.Concomitant medical device reported: variable angle condylar plate, stainless steel, left, 10 hole (part # unknown, lot # unknown, quantity 1) this is report number 2 of 2 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5722415
• MDR Text Key: 47288612
• Report Number: 2520274-2016-13146
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• 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
• Treatment: VARIABLE ANGLE CONDYLAR PLATE (PART # UNKNOWN)
• Patient Outcome(s): Required Intervention