MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE / 16 HOLE/ 336MM / RT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.416S

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.Additional device product codes are: hrs and hwc.Implant date is unknown.The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received.The investigation could not be completed; no conclusion could be drawn, as the subject device is entering the complaint system.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 (b)(4) reported an event in (b)(6) as follows: it was reported that the patient underwent revision surgery on (b)(6) 2015 to treat non-union of a right distal femur fracture and to replace a bent variable angle locking compression (va-lcp) condylar plate.It was reported that the plate had bent into a varus deformity (hyper trophic non-union).The surgeon attributed this plate failure due to a sub-optimal working length across the fracture and not an implant failure.The patient was revised with a new va-lcp condylar plate.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.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.

Manufacturer Narrative

Date of post-operative non-union is unknown.Concomitant screws: the following screws were identified as concomitant for this event.02.231.216 - 5.0mm variable angle locking screw/slf-tpng/strdrv/16mm.02.231.232 ¿ 5.0mm variable angle lockng screw/slf-tpng/strdrv/32mm.02.231.240 - 5.0mm variable angle lockng screw/slf-tpng/strdrv/40mm.02.231.238 - 5.0mm variable angle lockng screw/slf-tpng/strdrv/38mm.02.231.260 - 5.0mm variable angle lockng screw/slf-tpng/strdrv/60mm.02.231.275 - 5.0mm variable angle lockng screw/slf-tpng/strdrv/75mm.02.231.270 - 5.0mm variable angle lockng screw/slf-tpng/strdrv/70mm.02.231.280 - 5.0mm variable angle lockng screw/slf-tpng/strdrv/80mm.Manufacturing investigation evaluation: part not received in the original sterile packaging.Some holes are visually damaged post production.Some screws returned together with the plate but are not part of this investigation as they are intact.The visual inspection of holes confirms that they are visibly damaged due to post-production events.As a result, they were not measurable.The undamaged holes were measured and found within specification.Considering that all the holes are manufactured with the same parameters and tools, the damaged holes were therefore manufactured in accordance with specifications as well.Based on this examination, the complaint is rated as confirmed, but not valid from a manufacturing point of view.No manufacturing related issues were identified and/or confirmed.No non-conformance reports were generated during production.Review of the device history records 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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE / 16 HOLE/ 336MM / RT-STER
• 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: 5220157
• MDR Text Key: 31008840
• Report Number: 1000562954-2015-10202
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 02.124.416S
• Device Lot Number: 8860832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention