MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415

Device Problems Bent (1059); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.An event date of (b)(6) 2015 was provided by the reporter but it is unknown if this was the date the plate actually bent and fractured or if this was the date it was discovered that the plate bent and fractured.The date the plate actually bent and fractured may be unknown.This report is for one unknown left va condylar plate, 14-hole.The reported part number, 02.124.514, is not a valid synthes part number.It is possible that the correct part number is 02.124.415 which corresponds to synthes 4.5mm variable angle locking compression curved condylar plate, 14-hole, 301mm length, left, device product codes¿(b)(4), common name¿plate, fixation, bone, (b)(4).A lot number was not provided by the reporter.The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) reports an event in (b)(6) as follows: it was reported that an unknown variable angle (va) condylar plate, 14-hole partially broke and bent approximately three weeks after implantation on (b)(6) 2015.There were no screws at the site where the plate fractured and bent.The plate was initially implanted to treat a left femoral fracture.Revision surgery was performed on (b)(6) 2015 and the plate was removed; however, other details regarding the revision surgery are unknown.This report is for one unknown left va condylar plate, 14-hole.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Dhr review - 02.124.415 ¿ (b)(4).Manufacturing site: (b)(4).Manufacturing date: 30.Apr.2012.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.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

Device manufacturing evaluation ¿ the plate was received in a minigrip.The reference numbers etched correspond with complaint references.The plate is bent and broken.Dhr review - no ncrs were generated during production.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.The coa of the raw material was reviewed, no anomaly found, the material was conforming to specification.Product inspection: the returned plate was reinspected for all the features pertinent to the complaint condition.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.The complaint is disposed as confirmed due to evidence that plate is broken, but it's considered not valid for (b)(4) because there is no evidence of issues manufacturing related.No manufacturing related issue was identified, therefore review to the specific prm and prm line is not applicable.The product investigation showed that the returned part is conforming from a manufacturing perspective.Complaint is disposed as confirmed due to evidence that plate is broken, but it's considered not valid for the manufacturer because there is no evidence of issues manufacturing related.Based on this, it is not possible to determine the exact reason for the reported problem, but it is likely that an overloading situation, as too much and/or too early weight bearing or strong body / bone movement from the patient led to this damage.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5306012
• MDR Text Key: 33740678
• Report Number: 2520274-2015-17951
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Device Lot Number: 7888144
• Other Device ID Number: (01)07611819454118(10)7888144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80