MAUDE Adverse Event Report: ZIMMER GMBH NCB TRAUMA PLATE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.Additional information was requested on april 20, 2017.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.Zimmers reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a ncb trauma plate (catalog and lot number unknown) in (b)(6) 2017 (exact date unknown) to fix a fracture.It was stated that the plate didn't hold the reduction.During the revision (date unknown) some of the screws were removed from the distal part of the lateral plate.After reduction was corrected a 3.5 plate was placed on the medial side of the femur and the screws were re implanted back into the distal lateral femur plate.

Manufacturer Narrative

Additional information has been requested and is currently not available.No trend analysis could be performed as no item number(s) is/are available.As no lot numbers were provided for the devices, the device history records could not be reviewed.An e-mail requesting missing device was sent to the complainant.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Event summary: it is reported that the patient had a ncb distal femur plate implanted in (b)(6) 2017.After unknown time, it is reported that the plate didn't hold the reduction the patient went into varus reduction and had to be revised.No medical data such as x-rays, surgical notes or any other case-relevant documents received.No product was returned to zimmer biomet for in-depth analysis.The ncb¿ distal femur system surgical technique contains all information regarding the indication, contraindications and steps to implant the plate.Root cause analysis: root cause determination using rmw: loss of fracture reduction before complete bone healing due to loosening of ncb df implant from the bone due to mechanical forces applied (torsion, bending,.) => possible, no information is available about the procedure used to implant the plate, and no documentation like surgical reports or x-rays to assess the fracture reduction, placement of the plate, size,& therefore this cannot be excluded.Additionally, the implant is not available for investigation and potential damage, bending,.Cannot be assessed.Loss of fracture reduction before complete bone healing due to thread-stripping/ screw seating/removal torque/axial load/ => possible, no information is available about the procedure used to implant the plate, and no documentation like surgical reports or x-rays to assess the fracture reduction, placement of the plate, size,& therefore this cannot be excluded.Additionally, the implant is not available for investigation and potential damage, bending,.Cannot be assessed.Loss of fracture reduction before complete bone healing due to loss of screw angular stability due to insufficient strength of the design not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Loss of fracture reduction before complete bone healing due to user connect the targeting device to wrong plate (l/r) => possible, no information is available about the procedure used to implant the plate, and no documentation like surgical reports or x-rays to assess the fracture reduction, placement of the plate, size,& therefore this cannot be excluded.Additionally, the implant is not available for investigation and potential damage, bending,.Cannot be assessed.Conclusion summary: it is reported that the patient had a ncb distal femur plate implanted in (b)(6) 2017.After unknown time, it is reported that the plate didn't hold the reduction the patient went into varus reduction and had to be revised.No information is available about the procedure used to implant the plate, and no documentation like surgical reports or x-rays to assess the fracture reduction, placement of the plate, size, etc.Therefore this cannot be excluded.Additionally, the implant is not available for investigation and potential damage, bending, etc.Cannot be assessed.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Possible root causes include mechanical forces applied to the plate, thread-stripping, screw seating, and wrong plate (l/r) used.However, it is unknown if these factors contributed to the reported issue and if yes to which extent.In conclusion, due to significant lack of information, an exact root cause cannot be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmers reference number of this file is (b)(4).

• Brand Name: NCB TRAUMA PLATE
• Type of Device: NA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6506838
• MDR Text Key: 73220743
• Report Number: 0009613350-2017-00515
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNWON
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/20/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention