MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT PLATE,FIXATION,BONE

Model Number 02.124.406

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6). Date of postoperative plate breakage is unknown. Additional device product codes: jdp, hwc. (therapy date): original surgery date (b)(6) 2017; exact date is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was performed for part # 02. 124. 406, lot # l343153: manufacturing location: (b)(4), manufacturing date: 24. Mar. 2017: no non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 the patient had original surgery in (b)(6) 2017 for treatment of a right distal femur fracture. Patient was implanted with one (1) 4. 5mm(va) variable angle locking compression curved condylar plate and eight (8) screws. Of the eight screws, one (1) 4. 5mm cortex screw was implanted at the shaft on the plate, and seven (7) 5. 0mm va locking screws were implanted in other plate hole screw positions. On an unknown date, post-operative, patient presented with a broken plate and one broken 4. 5mm cortex screw. The plate was broken at the broken cortex screw position. On (b)(6) 2017, surgeon removed all implants and revised the patient to a longer va locking plate and screws. It was reported that all screws, the plate and any fragments were retrieved. All implants have been retained by the hospital. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. Concomitant devices reported:5. 0mm va locking screws (part # unknown, lot # unknown, quantity 7) this report is for one (1) 4. 5mm va-lcp curved condylar plate/6 hole/159mm/right this is report 1 of 2 for complaint (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT
• Type of Device: PLATE,FIXATION,BONE
• 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: 6915222
• MDR Text Key: 88209832
• Report Number: 1000562954-2017-10226
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982042736
• UDI-Public: (01)10886982042736(10)L343153
• 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

• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 02.124.406
• Device Catalogue Number: 02.124.406
• Device Lot Number: L343153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/05/2017 Patient Sequence Number: 1

Treatment

SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 7)