MAUDE Adverse Event Report: SYNTHES USA 5.0MM CANNULATED VA LOCKING SCREW/85MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.685

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.Unknown when screw became loose and backed out.The investigation could not be completed; no conclusion could be drawn.The lot number provided could not be verified; therefore, further investigation cannot be performed.One of the following device(s) was received: 4.5mm va-lcp curved condylar plate (part # 02.124.411 | lot # 9237095); 5.0mm cannulated va locking screw (part # 02.231.690| lot # unknown); 5.0mm cannulated va locking screw (part # 02.231.685| lot # unknown); 5.0mm cannulated va locking screw (part # 02.231.680| lot # unknown) - qty.2; 5.0mm cannulated va locking screw (part # 02.231.675| lot # unknown); 5.0mm va locking screw (part # 02.231.244| lot # unknown); 5.0mm va locking screw (part # 02.231.238| lot # unknown); 4.5mm cortex screw (part # 214.842 | lot # unknown); 4.5mm cortex screw (part # 214.836 | lot # unknown).A total of eleven (10) implants were received.All devices show signs of being implanted.The plate is intact with cosmetic scratches along its surface.All nine (9) screws had damage to the stardrive recess consistent with insertion and removal.The threads on 42mm cortex screw were rolled.The exact cause for the screw loosening could not be determined.A visual inspection, functional test, complaint history review, and a drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Since no x-rays were received, the complaint condition was unable to be confirmed.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 orif (open reduction internal fixation) of a supracondylar femoral fracture on (b)(6) 2015.Hardware failure occurred sometime after the initial procedure.X-rays showed that the five 5.0 cannulated screws were backing out at the head of the plate.On (b)(6) 2015, the surgeon removed all hardware (plate and 9 screws).The patient will have further surgery on a date to be determined.Also reported, the patient underwent an orif (open reduction internal fixation) of a supracondylar femoral fracture on (b)(6) 2015.Hardware failure occurred sometime after the initial procedure.X-rays showed that the distal 5.0 cannulated va locking screws were backing out of the head of the plate.On (b)(6) 2015 the screws that were backing out were replaced with new 5.0 va cannulated locking screws.On (b)(6) 2015, the surgeon removed all hardware (plate and 9 screws) secondary to failure again.The sales consultant stated that the 5.0 va cannulated locking screws (5) that were previously replaced on (b)(6), were backing out at the head of the plate once again.The patient status is unknown at this time.The patient will have further surgery on a date to be determined for definitive treatment.This report is 1 of 5 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional information: patient medical record number is (b)(4).Additional and corrected information was received on august 26, 2015.Additional and corrected information was received on august 26, 2015.A product development investigation was performed for the subject device (part number, 02.231.685, 5.0mm cannulated va locking screw/85mm, lot number unknown).The subject device was received showing signs of having been implanted.The screw has damage to the stardrive recess consistent with insertion and removal.The exact cause for the screw loosening could not be determined.A visual inspection, functional test and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned device was determined to be suitable for the intended use when employed and maintained as recommended.Since no x-rays were received, the complaint condition was unable to be confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on august 26, 2015.It was reported that a patient underwent an orif (open reduction internal fixation) of a supracondylar femoral fracture on (b)(6) 2015.On an unknown date after the initial procedure, x-rays showed that the distal 5.0 cannulated va locking screws were backing out of the head of the plate.On (b)(6) 2015, the screws that were backing out were replaced with new 5.0 va cannulated locking screws.On (b)(6) 2015, the surgeon removed all the hardware (plate and nine screws) due to secondary failure.It was further reported that the five, 5.0 va cannulated locking screws that were previously replaced on (b)(6) 2015 were backing out at the head of the plate once again.The patient status is unknown at this time.The patient will have further surgery on a date to be determined for definitive treatment.The first revision surgery performed on (b)(6) 2015 is addressed under a separate complaint, (b)(4).This complaint and associated medwatch reports address the second revision surgery performed on (b)(6) 2015.This report is 2 of 6 for (b)(4).

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/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: 5046796
• MDR Text Key: 24757923
• Report Number: 2520274-2015-15587
• 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
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 147