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

Model Number	02.124.409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.(b)(6).(b)(4).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 - 02.124.409 and lot # l462853, manufacturing location: (b)(4), manufacturing date: 27.Jun.2017.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.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 underwent a hardware removal and revision on (b)(6) 2017.The original procedure was performed on (b)(6) 2017, to repair a left comminuted distal femur fracture.Subsequently, the patient sustained a fall which bent the originally implanted plate and caused a loss of reduction.Nothing untoward occurred during the revision procedure.Removed hardware included: one plate (bent) and a combination of 4.5 mm cortex and 5.0 mm variable angle (va) locking screws (all intact).The femur was re-reduced, and the patient was revised to a new longer plate and screws.The procedure was completed successfully with the patient in stable condition.There was no surgical delay.This complaint involves one (1) device.Concomitant devices reported: unknown 4.5 mm cortex screws (quantity - 6), unknown 5.0 mm va locking screws (quantity - 4).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.The investigation summary indicates that the: patient underwent a hardware removal and revision on (b)(6) 2017.The original procedure was performed on (b)(6) 2017, to repair a left comminuted distal femur fracture.Subsequently, the patient sustained a fall which bent the originally implanted plate and caused a loss of reduction.Customer quality (cq) engineering investigation: the returned plate is bent as reported.The bend occurred at the transition from diaphyseal to metaphyseal plate regions.The plate shows post manufacturing damage consistent with implantation and explantation.Whether this complaint an be replicated at customer quality (cq) is not applicable for this complaint condition.The returned plate is designed for load sharing while the bone heals and would not be expected to maintain its shape during a traumatic event such as a fall by the patient who was reportedly (b)(6) lbs.A visual inspection under 5x magnification, dimensional inspection, device history record (dhr) review and drawing review were performed at cq for the returned device as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The returned plate is bent as reported.The bend occurred at the transition from diaphyseal to metaphyseal plate regions.The plate shows post manufacturing damage consistent with implantation and explantation.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 7044926
• Report Number: 1000562954-2017-10265
• Device Sequence Number: 11238168
• Product Code: HRS
• UDI-Device Identifier: 10886982042798
• UDI-Public: (01)10886982042798(10)L462853
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/26/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.124.409
• Device Catalogue Number: 02.124.409
• Device Lot Number: L462853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/18/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK 4.5MM CORTEX SCREWS PART/LOT UNK, QTY 6; UNK 5.0MM VA LOCKING SCREWS, QTY 4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 113