MAUDE Adverse Event Report: SYNTHES (USA); IMPLANT, FIXATION DEVICE CONDYLAR PLATE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Additional device product codes are hrs and hwc.This report is for an unknown quantity of unknown screws which reportedly loosened postoperatively.Other number¿udi: unknown part number, udi is unavailable.It is unknown which of the following screws reportedly implanted in the patient loosened postoperatively: 02.234.242, part number invalid screws, lot l053067, qty 2, 510(k) unknown, common name¿screw, fixation, bone, device product code hwc.Other number¿udi: part number unknown, udi is unavailable.02.231.242, 5.0mm va lockng screw 42mm, lot 9856271, qty 2, 510(k) k110354, common name--implant, fixation device condylar plate, device product codes jdp, hrs, and hwc.Other number¿udi: (b)(4).02.231.300, 5.0mm va lockng screw 42mm, lot 9530481, qty 1, 510(k) k110354, common name--implant, fixation device condylar plate, device product codes jdp, hrs, and hwc.Other number¿udi: (b)(4).02.231.295, 5.0mm va lockng screw 95mm, lot 9804639, qty 1, 510(k) k110354, common name--implant, fixation device condylar plate, device product codes jdp, hrs, and hwc.Other number¿udi: (b)(4).02.231.295, 5.0mm va lockng screw 95mm, lot 9942467, qty 1, 510(k) k110354, common name--implant, fixation device condylar plate, device product codes jdp, hrs, and hwc.Other number¿udi: (b)(4).02.231.290, 5.0mm va lockng screw 90mm, lot 9859213, qty 1, 510(k) k110354, common name--implant, fixation device condylar plate, device product codes jdp, hrs, and hwc.Other number¿udi: (b)(4).02.231.290, 5.0mm va lockng screw 90mm, lot 9951705, qty 1, 510(k) k110354, common name--implant, fixation device condylar plate, device product codes jdp, hrs, and hwc.Other number¿udi: (b)(4).The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.Reporting facility phone number is (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review will be request for the subject device lots.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 europe reported an event in (b)(6) follows: it was reported that revision surgery was performed on (b)(6) 2017 due to loss of reduction and plate integrity.The initial open reduction and internal fixation (orif) procedure was performed on the patient¿s distal femur on (b)(6) 2016.Follow up x-ray taken on (b)(6) 2017, showed a slight bend in the variable-angle-locking compression plate (va-lcp) condylar plate.Follow up x-ray taken on (b)(6) 2017 showed a significant bend in the va-lcp condylar plate.Revision orif distal femur case was performed on (b)(6) 2017 due to the loss of reduction due to loss of plate integrity.In discussions during the case the surgeon said the distal locking screws were sitting proud and no longer locked into the plate.He felt that the bridged distance around the fracture site was too large and that the independent cortex screws were not needed.Revision was to another 16-hole va-lcp curved condylar plate.The patient had normal post-operative recovery.Concomitant devices cortex screw 2x (part 214.842/ lot: 9773409+ 204.838.Lot.2404492).This report is for an unknown quantity of distal locking screws which reportedly loosened postoperatively.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history records for the potential part/lot numbers was completed: part 02.231.242, lot l053067, quantity 2: manufacturing location: (b)(4).Manufacturing date: july 06, 2016; part 02.231.242, lot 9856271, quantity 2: manufacturing location: (b)(4).Manufacturing date: march 02, 2016; part 02.231.300, lot 9530481, quantity 2: manufacturing location: (b)(4).Manufacturing date: july 10, 2015; part 02.231.295, lot 9804639, quantity 1: manufacturing location: (b)(4).Manufacturing date: january 21, 2016; part 02.231.295, lot 9942467, quantity 1: manufacturing location: (b)(4).Manufacturing date: may 09, 2016; part 02.231.290, lot 9951705, quantity 1: manufacturing location: (b)(4).Manufacturing date: may 18, 2016; part 02.231.290, lot 9859213, quantity 1: manufacturing location: (b)(4).Manufacturing date: march 08, 2016.No non-conformance reports 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.A manufacturing evaluation was completed: the plate is significantly bent.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.In the certificate of raw material it is reported that the material fulfills the specification.The returned part was re-inspected for all the features pertinent to the complaint condition and all features were found to have been manufactured to the correct specifications.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.No manufacturing related issue was identified.Complaint is disposed as confirmed due to evidence that part is bent, but it's considered not valid for manufacturing site because there is no evidence of issues manufacturing related.Unfortunately we are not able to determine the exact reason for this occurrence.A product investigation was completed: in additional to the plate, 10 va locking screws were also received.Upon visual inspection, it was noted that all screws are damaged at the screw head thread, also some of the screws are damaged at shank.It is unknown which of the va locking screws it was loosened postoperatively.Unfortunately we are not able to determine the exact reason for this occurrence; however it is likely that the screw/screws backed out due to the damage (screw head thread) from insertion.Two concomitant cortex screws (part 214.842, lot 9773409 and part 204.838, lot 2404492) were received and it was determined these parts are not responsible for the plate bending and not backed out.It was noted that the plate deformation could be confirmed when the x-rays were reviewed by the manufacturer.No product fault could be detected.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.

• Type of Device: IMPLANT, FIXATION DEVICE CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6354486
• MDR Text Key: 68179818
• Report Number: 2520274-2017-10589
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: (B)(4), 3.5MM CORTEX SCREW 38MM, QTY 1; (B)(4), 4.5MM CORTEX SCREW 42MM, QTY 1
• Patient Outcome(s): Other; Required Intervention