MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number	02.124.412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: hrs, hwc.Manufacturing location: (b)(4).Manufacturing date: july 26, 2013.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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 or Problem Description
It was reported that a patient, who underwent an open reduction internal fixation of the distal right femur on (b)(6) 2016, had a revision surgery on (b)(6) 2017, after the plate was noted to be broken and the patient suffered a non-union.On an unknown date the post-operative non-union and broken plate was noted.The plate, broken at a screw hole (fourth combi hole from the bottom) and twelve (12) intact screws were all easily removed.It is unknown if the patient had a complaint of pain.The patient was revised with an antegrade/retrograde femoral nail, one spiral blade and four, 5.0 mm locking screws.The surgeon also used the reamer irrigator aspirator system to harvest bone graft from both femurs.The bone graft material was implanted in conjunction with the nail.Standard cultures were taken as a precaution, but the surgeon did not suspect an infection.The surgery was successfully completed with no delays and the patient was reported to be stable at the end of the procedure.Concomitant devices reported: screws (quantity 12).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Manufacture investigation: it was reported that a patient suffered from a broken plate and non-union.The returned 12 hole 4.5mm va-lcp curved condylar plate (02.124.412, lot 8546479, mfg 26-jul-2013) was evaluated at customer quality and the complaint condition was able to be confirmed.The plate had a transverse fracture across the va locking hole of the 4th combi-hole distal to the condylar head.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.Additionally, the calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The following part(s) were returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on the device(s).The concomitant cannulated locking screw has damaged threads.Unk cortex screw (qty 5) unk cannulated locking screw (qty 1) unk locking screw (qty 6) 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 (reference technique guide (b)(4)).Drawing for the device was reviewed.No drawing issues or discrepancies were noted.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The plate thickness nearest the break measured 5.79mm (calipers (b)(4)) at cq on both plate pieces which is within specification of 5.4mm - 5.8mm per product drawing.The plate width nearest the break measured 17.90mm and 17.92mm (calipers (b)(4)) at cq on the shaft of the condylar fragment and the shaft only fragment respectively which is within specification of 17.4mm - 18.0mm per product drawing.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.Part number: 02.124.416 complaint category: broken: postoperatively part family: 0x.124.406 to 0x.124.423 [4.5mm va-lcp curved condylar plates] (x denotes a 2 or 4) the 4.5mm va-lcp curved condylar plate design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition.A root cause could not definitively be determined.It is likely that excessive mobilization contributed to the complaint condition.(b)(6).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 or Problem Description
Concomitant devices reported: cortex screw (part number unknown, lot number unknown, quantity 5), cannulated locking screw (part number unknown, lot number unknown, quantity 1), locking screw (part number unknown, lot number unknown, quantity 6).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
• Common Device Name: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6593772
• Report Number: 1000562954-2017-10089
• Device Sequence Number: 13772684
• Product Code: JDP
• UDI-Device Identifier: 10886982042859
• UDI-Public: (01)10886982042859(10)8546479
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02.124.412
• Device Lot Number: 8546479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/16/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68