MAUDE Adverse Event Report: SYNTHES (USA) 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/85MM; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Catalog Number 02.231.285

Device Problem Failure to Capture (1081)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported that a patient was originally implanted with synthes variable angle (va) locking compression plate (lcp) and screws on (b)(6) 2014 for a left distal third femur fracture.Subsequently, it was clinically determined that the patient experienced a non-union.Five locking screws in the distal segment of the va-lcp did not hold their angle.All hardware was removed (b)(6) 2015.The patient was revised with a combination of synthes and competitor¿s devices.Surgery was successfully completed with no additional delays or medical interventions required.Patient status was reported as fine.This is report 2 of 6 for (b)(4).

Manufacturer Narrative

(b)(4).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.

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/85MM
• Type of Device: IMPLANT,FIXATION DEVICE,CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4551651
• MDR Text Key: 5456459
• Report Number: 2520274-2015-11270
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• 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
• Patient Weight: 89