MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.411

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

Patient Problem No Code Available (3191)

Event Type  Injury  

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 nine (9) screws).The patient will have further surgery on a date to be determined.(b)(4).

Manufacturer Narrative

Patient information is unknown date of event: unknown.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Manufacturing date: 10 november 2014.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

Additional narrative: additional product codes: hrs, hwc.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 (b)(4) implants were received.All devices show signs of being implanted.The plate is intact with cosmetic scratches along its surface.All (b)(4) 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.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).A product development investigation was performed for the subject device (part number 02.124.411, 4.5mm va-lcp curved condylar plate, lot number 9237095).The subject device was received showing signs of having been implanted.The plate is intact with cosmetic scratches along its surface.The exact cause for the screws loosening (see associated reports) 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 (b)(4) 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 july 10, 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 6 of 6 for (b)(4).

Manufacturer Narrative

The subject device implant date was corrected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/10 HOLE/230MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4952448
• MDR Text Key: 6255898
• Report Number: 1000562954-2015-10157
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.411
• Device Lot Number: 9237095
• 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
• Date Device Manufactured: 11/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 147