MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CPM 11.5MM X 34CM 130 L; ZIMMER NATURAL NAIL SYS.CEPHALO.NAILS

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a fracture of the nail in the area of the femoral neck screws without trauma.Patient involvement.
Additional Manufacturer Narrative
Photographs were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.No further due diligence required as all required information to support the conclusion is available or was already requested.Devices are used for treatment.The product combination was approved by zimmer biomet.Review of received pictures show that the nail was fractured at the lag screw hole.The reported event can be confirmed.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Review of received surgical reports: 3 surgical reports were received (dated 09.10.2021, 12.10.2021 and 11.02.2022).The surgical report dated (b)(6) 2021 describes the implantation of a zimmer nailing system due to femoral fracture left.The surgeon had some difficulties in insertion of the nail.No other abnormalities were found.The surgical report dated (b)(6) 2021 (3 days later of the implantation) describes a bone fracture (schaftsprengung) and the revision of the nailing system.The nailing system was removed and a long cmn nail was implanted.The report also mentions that this was a difficult surgery.The surgical report dated (b)(6) 2022 describes a fracture of the cmn nail.The fracture of the patient was not consolidated.The nail was removed and a stem sps was implanted.Review of received x-rays: there are 4 undated x-ray pictures available for investigation.It can be seen that the fracture was fixated with some cerclage wires.The breakage of the nail can be confirmed on the x-ray pictures.The investigation did not identify a nonconformance or a complaint out of box (coob).The breakage of the znn nail could be confirmed on the x-ray picture.The surgical report dated (b)(6) 2022 mentioned that the fracture was not consolidated.However, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: Z NAIL CPM 11.5MM X 34CM 130 L
• Common Device Name: ZIMMER NATURAL NAIL SYS.CEPHALO.NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13769609
• Report Number: 0009613350-2022-00162
• Device Sequence Number: 4029824
• Product Code: HSB
• UDI-Device Identifier: 00889024299535
• UDI-Public: 00889024299535
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 47-2493-343-11
• Device Lot Number: 3034124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 51 KG