MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/8HOLE/195MM/LT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.409S

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional product codes: hrs, hwc.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

It was reported that a patient had an original surgery for open reduction internal fixation (orif) on an unknown date to treat a left distal femur fracture using a 4.5 mm variable angle locking compression plate (va-lcp) curved condular plate-8 hole-195 mm left and various screws.X-ray taken on (b)(6) 2017 revealed the six (6) distal locking screws at the head of the plate were loose and were backing out of the plate.X-ray also revealed patient had developed an abscess of the lower left extremity.On (b)(6) 2017, the patient underwent revision surgery during which the six(6) distal locking screws were removed.Surgeon also treated the infection with irrigation and debridement of the wound, and placement of antibiotic beads.The surgeon then placed six (6) new distal locking screws into the existing plate which was not removed.There were also five (5) unknown screws in the shaft of the plate, and two (2) unknown cancellous screws holding the condyle bone in place which were intact and not loose, that were not removed.There were no broken fragments and the procedure was completed successfully.The patient remained in stable condition during and following the surgery.This report is for one (1) 4.5 mm va-lcp curved condylar plate-8 hole-195 mm-left.This is report 1 of 5 for (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that six distal locking screws from the head of a 4.5mm va-lcp curved condylar plate construct had backed-out postoperatively requiring a revision procedure.The six screws were removed and replaced following treatment for infection: irrigation, debridement and placement of antibiotic beads.A preoperative x-ray from the revision procedure was provided which confirmed screws had backed out from the plates head.As the devices were not returned and insufficient information was provided to identify the product family of the screws, no further investigation is possible.The 4.5mm va-lcp curved condylar plate (02.124.409s) is a component of the 4.5mm variable angle lcp curved condylar plate set (01.231.015) which is utilized in the 4.5mm va-lcp curved condylar plate system.The system is indicated for buttressing multi-fragmentary distal femoral fractures and features plates which contain combi hole shafts and heads with five variable angle screw holes, where screws can be angled within a 30-degree cone around the central axis of the plate hole, and one central fixed angle locking hole.X-rays provided with the complaint were reviewed and the complaint condition was able to be confirmed as multiple screws in the plate head were observed to be backed out of the plate.Based on the available information, no further investigation, including drawing review and occurrence rate, was able to be completed as insufficient information was provided to determine the screw families of the backed-out screws; the system contains 5.0mm va locking screw, 5.0mm cannulated va locking screw and 5.0mm periprosthetic va locking screw families, each of which are able to be implanted in the plate¿s head va and fixed angle holes.No device history reviews could be completed as part and lot information for the affected products were not provided.No material or dimensional analysis could be completed as devices were not returned for investigation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint is confirmed.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/8HOLE/195MM/LT-STER
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7033318
• MDR Text Key: 92075646
• Report Number: 1000562954-2017-10256
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• 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,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.409S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 93