MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/RIGHT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.408

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional product code: hwc implant date reported as (b)(6) 2016.Concomitant devices reported: unknown 5.0mm locking stardrive screw (part # unknown, lot # unknown, quantity # 10).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part # 02.124.408; lot # 9312808, manufacturing site: (b)(4), manufacturing date: 14.Jan.2015.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 plate was reported as broken and required revision surgery.Upon receipt of the device it was found the plate was cracked.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 a hardware removal and revision was performed on (b)(6) 2017 due to a broken 8-hole distal femur plate and femur non-union.The original procedure was performed in (b)(6) 2016.Subsequently, it was discovered that the plate had broken in two places.The removed hardware included: one (1) 4.5mm variable-angle (va)-locking compression plate (lcp) curved condylar plate/8 hole/195mm/right (which had broken in two places), and ten (10) 5.0mm locking stardrive screws (all intact).The breaks on the plate occurred at the sixth distal anterior hole and the seventh distal combi hole on the va posterior locking side.The patient was revised to a femoral nail.There were no reported surgical delays, no fragments involved and no additional x-rays required.The procedure was completed successfully with the patient in stable condition.This complaint involves one (1) device.Concomitant devices reported: unknown 5.0mm locking stardrive screw (part # unknown, lot # unknown, quantity # 10).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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 used for treatment, not diagnosis.Product code: jdp.Additional product codes: hrs, hwc.Initial date received by manufacturer: jun 19, 2017.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product evaluation was performed.The investigation of the complaint articles indicates that the: customer quality (cq) engineering investigation: this complaint is confirmed.However, it was reported that the plate broke in two places, whereas the returned plate is cracked in two places.The plate is still in one piece (no fragments generated).Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device cracked postoperatively.No new malfunctions were identified as a result of the investigation.The returned device is part of the 4.5mm va-lcp curved condylar plate system and is indicated for buttressing multi fragment distal femur fractures.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.Visual inspection at cq: however, it was reported that the plate broke in two places, whereas the returned plate is cracked in two places.The plate is still in one piece (no fragments generated).No product design issues or discrepancies were observed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: subject device was received, changed code (b)(4).Device 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/8 HOLE/195MM/RIGHT
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6718055
• MDR Text Key: 80197033
• Report Number: 1000562954-2017-10132
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042774
• UDI-Public: (01)10886982042774(10)9312808
• 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,Followup,Followup,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.408
• Device Catalogue Number: 02.124.408
• Device Lot Number: 9312808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 07/21/2017; 07/25/2017; 08/01/2017
• Supplement Dates FDA Received: 07/17/2017; 07/21/2017; 07/28/2017; 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 136