MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, SHAFT PLATE, STRAIGHT, NARROW, 10 HOLES, 146 MM; NCB STRAIGHT NARROW SHAFT PLATES

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to periprosthetic fracture.
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to periprosthetic fracture.
Additional Manufacturer Narrative
Additional information which was received on jan 07, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Additional Manufacturer Narrative
Event description: it was reported that a female patient had a bone fracture which was treated with a ncb straight plate on (b)(6) 2018.Postoperatively, the bone and plate fractured and the patient underwent revision surgery on (b)(6) 2018, approx.6 weeks after implantation.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Surgical report: a copy of the initial and subsequent operation was provided on a word-document.Implantation report from (b)(6) 2018: findings: significant callus and scar tissue formation.Procedure: incision, approach.Radial nerve identified distally and tracked proximally.Protected throughout.Anterolateral attachment of deltoid lifted off to aid exposure.Fracture identified and cleared of soft tissue and callous.Edges freshened.Reduced.Held with 10 hole ncb plate.Moderate compression achieved across fracture site using plate.Deltoid reattachment with orthocord suture around plate.Final images checked and saved.Washout.Closure in layers.Surgical report from (b)(6) 2018: findings: comminuted para-iimplant(plate and screws) of humerus shaft.Poor bone stock.No prurulent secretion noted.Samples from humerus canal/fracture site sent for mcs.No sign of callus.Procedure: sharp/blunt dissection.Previous sutures over fascia removed.Haemostasis radial nerve identified from distal to proximal and protected throughout.Plate and screws removed.Distal screws were loose.Fracture site debrided.Copious washout with normal saline.Canal hand reamed poor bone stock: decided to proceed with i.M nailing.Reduction achieved using reduction clamps guide wire position after splitting of rotator cuff.1cm postero-medial to bicep groove over gt canal prepared and measured.Size 8 x260 acumed nail implanted with 2 x proximal screws l-m and 1 distal screw a-p.Reduction reinforced using arthrex fibertape cerclage system.Stable fixation.Final images saved to pacs.Rotator cuff repaired using orthocod.Deltoid trans-osteo re-insertion with orthocod.Copious washout with normal saline.Surgical time: 3.5 hours.800mls blood lost.Re-transfused 350mls in theatre using cell savage.Patient data: patient data: female, 79kg.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Instruction for use (ifu): contraindications: lack of bone substance or poor bone quality which makes stable seating of the implant impossible.Conclusion: it was reported that a female patient had a bone fracture wich was treated with a ncb straight plate on (b)(6) 2018.Postoperatively, the bone and plate fractured and the patient underwent revision surgery on (b)(6) 2018, approx.6 weeks after implantation.Neither x-rays, office visit notes, nor device(s) or photos of the device(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may have affected the performance of the components such as activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.In the revision surgery report dated (b)(6) 2018 it was reported that poor bone stock was noted.Adherence to rehabilitation protocol is unknown.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that a patient underwent revision surgery due to plate fractured approx.6 weeks after implantation.

• Brand Name: NCB, SHAFT PLATE, STRAIGHT, NARROW, 10 HOLES, 146 MM
• Common Device Name: NCB STRAIGHT NARROW SHAFT PLATES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11036422
• Report Number: 0009613350-2020-00599
• Device Sequence Number: 19104423
• Product Code: HRS
• UDI-Device Identifier: 00889024484702
• UDI-Public: 00889024484702
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2021

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.02267.010
• Device Lot Number: 2940092
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/07/2021; 05/28/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/19/2021; 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 79