MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, LEFT 10 MM, 36 CM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Therapy date : (b)(6) 2018.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on left side and underwent revision due to pain, implant fracture.

Event Description

Please refer to report 0009613350-2018-01242.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: e1 - h2 - h6.Correction: b4 - g4 - g7 - h10.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: breakage event description: product was implanted on may 25, 2018 and revised on nov 13, 2018 due to implant fracture and pain.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion: product was implanted on (b)(6) 2018 and revised on (b)(6) 2018 due to implant fracture and pain.The znn nail was in vivo for approximately 6 months.No product was returned to zimmer biomet for in-depth analysis.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant were received; therefore the condition of the component is unknown.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.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information and performed investigation, an exact root cause for the nail breakage could not be determined.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).

• Brand Name: CMN FEMORAL NAIL, CCD 125, LEFT 10 MM, 36 CM
• Type of Device: CMN FEMORAL NAIL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8168401
• MDR Text Key: 130465003
• Report Number: 0009613350-2018-01242
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024299641
• UDI-Public: 00889024299641
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

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: 47-2493-361-10
• Device Lot Number: 2835326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention