MAUDE Adverse Event Report: SYNTHES MEZZOVICO 5.0MM VARIABLE ANGLE LOCKNG 5.0MM VARIABLE ANGLE LOCK; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.238

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product codes: hrs, hwc.(b)(6).Device history records was conducted.The report indicates that the 02.231.238 - 9446086, manufacturing site: (b)(4).Manufacturing date: 15.Apr.2015 expiry date: 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.An product investigation summary was performed.The investigation of the complaint articles has shown that: we have forwarded the received parts to the responsible person in the sustaining engineering department for evaluation, here are the findings: the x-ray revealed that 3 va-locking-screws were unlocked and backed out of the head of the plate, but, it could not confirm how many screws were loose or the associated part numbers.Closer examination of the article 02.231.265 (lot 9501984), article 02.231.270 (lot 9361254) and article 02.231.255 (lot 9603458) va locking screws reveals an extensive amount of thread deformation of the locking screw heads.However, afterwards it cannot be defined if these damage occurred during the insertion, in-situ or during the extraction of the screws, therefore, the exact cause for the back out of the screws could not be determined.Based on the surgical technique review the final tightening of the va locking screws must be done by hand using the t-handle with torque limiting function 6 nm.Furthermore, the surgical technique states; "for off-axis drilling, insert the drill bit through the cone-shaped end of the drill sleeve at the desired angle to prevent drilling beyond 15 degrees." if a va-locking-screw is insert beyond 15 degrees the screw won't probably lock, although, the t-handle with torque limiting function 6 nm was used.Not following these advices above might have supported the back out of the screws.The back out of at least 3 va-locking-screws within the construct has significantly minimized the strength of the entire construct compounded.However, evaluating the provided complaint description, provided x-ray as well as locking at the returned product no clear root cause can be determined and there might be multiple causes that lead to the clinical hazard.The returned devices were received clean, and besides the marks of use, the screws show no visual deviations.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that revision of distal femur malunion performed on (b)(6) 2016 by dr (b)(6) at (b)(6) hospital.Patient had distal femur fracture treated with va-curved condylar plate and screws on (b)(6) 2015.Male patient, (b)(6), date of birth (b)(6) 1982.This report is 9 of 17 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG 5.0MM VARIABLE ANGLE LOCK
• 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: 5521592
• MDR Text Key: 41008889
• Report Number: 1000562954-2016-10070
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.238
• Device Lot Number: 9446086
• Other Device ID Number: (01)07611819451186(10)9446086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 100