MAUDE Adverse Event Report: SYNTHES MEZZOVICO 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/90MM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.290

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hrs and hwc.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number the device history records review could not be completed.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 underwent revision surgery due to a nonunion, loss of reduction, and back out of screws on (b)(6) 2016.Initially, the patient had an open reduction internal fixation (orif) of a distal femur due to a fall on (b)(6) 2016.The patient was implanted with one (1) 4.5mm variable angle (va) locking compression plate (lcp) and thirteen (13) screws of various types.No issues were reported during the initial surgery.Postoperatively, on unknown date and for unknown reason, the patient returned to the hospital and during that visit was seen by the surgeon.The surgeon noted that one of the screws was sticking out of her incision and he immediately pulled the screw out.X-rays taken on unknown date for unknown reason showed that most of the distal locking screws have completely backed out.The patient also had a nonunion and loss of reduction.It is unknown if the patient experienced any adverse events.During the revision surgery all hardware was easily removed and was intact.No additional medical intervention required.Patient was revised to another 4.5mm va lcp and approximately seventeen (17) screws.In addition, it was surgeon¿s preference to add two (2) cables.Revision surgery was successfully completed without surgical delay.Patient status/outcome was reported as stable.Concomitant devices reported: 4.5mm variable angle locking compression plate (part 02.124.413, lot 8457878, quantity 1); 4.5mm cortex screw self-tapping 40mm (part 214.840, lot unknown, quantity 1); 4.5mm cortex screw self-tapping 38mm (part214.838, lot unknown, quantity 1); 4.5mm cortex screw self-tapping 38mm (part 214.870, lot unknown, quantity 1); cortex screw (part/lot unknown quantity 1).This is report 1 of 10 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: january 16, 2014.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 product investigation was completed: the returned locking screws were examined and no defects or deficiencies which may have contributed to the complaint condition were identified.The proximal locking threads were found to be well defined for each returned screw.Additionally the returned plate was examined and minor wear consistent with screw implantation/explantation was noted in multiple distal variable angle locking holes.No definitive root cause was able to be determined with the provided information.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, risk assessment review and device history review were performed as part of this investigation.No product design issues or discrepancies were observed.The following concomitant devices were returned without allegation: 4.5 mm cortex screws (214.830, 214.840 and 214.870) and 4.5 mm va lcp curved condylar plate (02.124.413 lot 8457878).The implants were examined and no defects or deficiencies were identified which may have contributed to the reported complaint condition.Per the technique guide, the 5.0 mm variable angle (va) locking screws and the 5.0 mm periprosthetic va locking screw are components of the 4.5 mm va-lcp curved condylar plate system.The 4.5 mm va-curved condylar system is indicated for buttressing multi-fragmentary distal femoral fractures and features a plate with va-combi holes in the shaft and va locking holes in the distal region.All locking screws must be manually tightened with the supplied 6nm torque limiting handle.Relevant drawings for the returned devices were reviewed (both current revision and from the time of manufacture): 5.0 mm va locking screw and 5.0 mm periprosthetic va locking screw.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned devices¿ lot numbers and no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Updated concomitant devices reported; manufacturing facility.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

Updated concomitant devices reported: concomitant device reported: 4.5 mm variable angle locking compression plate (part 02.124.413, lot 8457878, quantity 1); 4.5 mm cortex screw (part 214.830, lot unknown, quantity 1); 4.5 mm cortex screw (part 214.840, lot unknown, quantity 1); 4.5 mm cortex screw (part 214.870, lot unknown, quantity 2).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/90MM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA 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: 6199293
• MDR Text Key: 63185596
• Report Number: 2520274-2016-15748
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.290
• Device Lot Number: 8800666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE PART 02.124.413, LOT 8457878, VA-LCP PLATE; ONE PART 214.840, LOT UNKNOWN, CORTEX SCREW; ONE PART 214.870, LOT UNKNOWN, CORTEX SCREW; ONE PART214.838, LOT UNKNOWN, CORTEX SCREW; ONE UNKNOWN CORTEX SCREW
• Patient Outcome(s): Required Intervention