MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 13 MM, 34 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date: detail of product: item number: 47248509510, item name: znn, cmn lag screw, 10.5 mm, 95 mm, including set screw, lot #: 2938330.Item number: 47248403750, item name: 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, lot #: 63779982.Item number: 47248404050, item name: 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, lot #: 63985506.Item number: 47248404250, item name: 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, lot #: 63869850.Item number: 47248700205, item name: cephalomedullary nail cap 5 mm height, lot #: 63880389.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.Additional information has been requested and is currently not available.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 or Problem Description
It was reported that patient underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: implant fracture.Event description: patient was implanted with a cmn femoral nail on (b)(6) 2018 and underwent revision surgery on (b)(6) 2018 due to fracture.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: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion: it was reported that the patient was implanted with a cmn femoral nail on (b)(6) 2018 and underwent revision surgery on (b)(6) 2018 due to fracture.The nail was in vivo for approx.5 months.Neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.It is known that the bone quality of the patient is inferior.The medical history of the patient: aortic aneurysm, cholecystitis and alcoholism.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.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
Please refer to report 0009613350-2018-01166.

• Brand Name: CMN FEMORAL NAIL, CCD 125, LEFT, 13 MM, 34 CM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8101537
• Report Number: 0009613350-2018-01166
• Device Sequence Number: 11261394
• Product Code: HSB
• UDI-Device Identifier: 00889024299481
• UDI-Public: 00889024299481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-341-13
• Device Lot Number: 2914731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR