MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.413

Device Problem Bent (1059)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Type  Injury  

Event Description

It was noted that the surgery was about two weeks previous to complaint being reported, but specific date is unknown.

Event Description

It was reported that an ortho distracter was used in surgery.It was also noted that two (2) screws were wasted during the procedure.The patient was admitted to a rehabilitation facility.The provided x-rays were reviewed by the manufacturer and it was noted that a screw pulled out and hardware failure.This is report 1 of 11 for (b)(4).

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

Additional narrative: product investigation evaluation: the complaint condition for the 4.5mm variable angle locking compression plate (lcp) curved condylar plate (part 02.124.413, lot 9138507) was likely caused by the impact of the patient falling; however, this complaint is not a result of any design related deficiency.No product issue was identified in the complaint or noted upon examination.The device was returned and reported to have become bent postoperatively due to a fall suffered by the patient.This condition is confirmed; the plate begins to bend at the third most distal combi-hole, at approximately fifteen (15) degrees from horizontal.It is likely that the impact from the fall suffered by the patient led to the bend seen in the plate.The device was manufactured in september 2014 and is less than a year old.The associated drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.It is likely that the impact from the fall suffered by the patient led to the bend seen in the plate.Device 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: 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.

Event Description

It was reported that the patient experienced hardware failure, which required revision surgery on (b)(6) 2015.The original implant date is unknown.The devices originally implanted include: a variable angle locking compression plate, quantity five of 5.5mm variable angle locking screws, and quantity four of 4.5mm cortex screws.Since the original surgery, the patient has fallen twice.The devices were removed without complications during the revision procedure.The plate was noted to be bent.No delay reported in surgery time.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Event date: unknown: dates of patient falls and plate bending are unknown.Additional device codes for this report include hrs and hwc.Date of original implant is unknown.Complainant device is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: (b)(4) - manufacturing date: september 16, 2014 - no non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Device 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.

Event Description

Update: additional information received april 23, 2015: per patient operating room (or) reports, the original surgery was an open reduction internal fixation (orif) procedure for a left femur periprosthetic fracture.This original procedure took place on (b)(6) 2015.The or reports indicated that "¿the proximal screw was then placed with the targeting guide.The screw was found to have missed the plate.The screw was then removed.The screw was then re-inserted and confirmed to be through the plate." a review of the records of utilized hardware determined the unknown screws to be 5.0 mm locking screws, not 5.5 mm.Additionally, the records show that there was a quantity of 4 (four) 5.0mm locking screws implanted.

Manufacturer Narrative

Additional narrative: additional patient information: patient¿s height was reported as (b)(6).Patient¿s medical record number is (b)(6).Device 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/12 HOLE/266MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4483366
• MDR Text Key: 5445436
• Report Number: 1000562954-2015-10037
• 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,Followup,Followup,Followup,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.413
• Device Lot Number: 9138507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 113