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 Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Hardware failure occurred sometime after the initial procedure, actual date unknown.Additional product codes: hrs, hwc.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 10.Nov.2014, no 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.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 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.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 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device was received and evaluated under related complaint (b)(4).Please refer to mdr report number 1000562954-2015-10157, medwatch reports (b)(4) for evaluation results.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 25 and 26, 2015: it was reported that on (b)(6) 2015, the surgeon removed all the hardware (plate and nine screws) due to the five previously replaced variable angle locking screws backing out a second time.This second revision surgery was addressed, evaluated and reported under related complaint (b)(4).This complaint addresses the first revision surgery performed on (b)(6) 2015 in which only the five locking screws were revised and replaced due to post-operative back-out.The plate was not removed during the (b)(6) 2015 surgery.

• 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: 5061952
• MDR Text Key: 25192431
• Report Number: 1000562954-2015-10181
• 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: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• 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: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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