MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 11.5 MM, 32 CM; CEPHALOMEDULLARY FEMORAL NAIL - LONG 11.5MM X 32CM 125 CCD LEFT TI-6AL-4V

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: znn, cmn lag screw, 10.5 mm, 100 mm, including set screw; catalog no#: 47-2485-100-10 ; lot#: 2933338.Cephalomedullary nail cap 0 mm height; catalog no#: 47-2487-002-00 ; lot#: 63978830.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog no#: 47-2484-032-50 ; lot#: 63948163.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog no#: 47-2484-035-50; lot#: 63979466.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.Where lot numbers were received for the explanted devices, 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 or Problem Description
Patient was implanted on the left side and underwent revision surgery due to cmn femoral nail fracture.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: 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: nail breakage.Event description: the initial surgery was performed with cm long nail on (b)(6) 2018.The revision surgery was performed with bha and gtr on (b)(6) 2018.Surgeon alleged that this event was because the patient could not comply with the load limit.Nail was fractured so revision surgery was performed.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: - all involved devices are intended for treatment.- the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion: the initial surgery was performed with cm long nail on (b)(6) 2018.The revision surgery was performed with bha and gtr on (b)(6) 2018.Surgeon alleged that this event was because the patient could not comply with the load limit.Nail was fractured so revision surgery was performed.The device manufacturing quality records indicate that the znn nail met all requirements to perform as intended.No product was returned to zimmer biomet for in-depth analysis.Therefore, the condition of the components is unknown.Neither x-rays, operative notes, office visit notes, nor photos of the explanted znn nail were received.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 investigation results did not identify a non-conformance or a complaint out of box (coob).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 - 2019 - 00020.

• Brand Name: CMN FEMORAL NAIL, CCD 125, LEFT, 11.5 MM, 32 CM
• Common Device Name: CEPHALOMEDULLARY FEMORAL NAIL - LONG 11.5MM X 32CM 125 CCD LEFT TI-6AL-4V
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8238955
• Report Number: 0009613350-2019-00020
• Device Sequence Number: 19228218
• Product Code: HSB
• UDI-Device Identifier: 00889024299290
• UDI-Public: 00889024299290
• 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): 07/23/2019

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: 47-2493-321-11
• Device Lot Number: 2928617
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention