MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125°, LEFT, ø 11.5 MM, 21.5 CM; IMPLANT, TRAUMA

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Bone Fracture(s) (1870); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a surgery in which a cm nail was used in a case of sub capital femoral fracture was performed.After insertion of the nail, the position of the nail was collapsed and the patient had to be repositioned with a cable.The alignment of the fracture site shifted as the nail was driven into the medullary cavity.Cm nail was used for subtrochanteric femoral fracture.Reduction position of the fracture site shifted as the nail was driven into the medullary cavity.Then the surgeon decided to use a cable to align this position, and while operating the cable passer, the patient bled profusely.Immediately after this hemorrhage, the patient went into cardiopulmonary arrest and the cm nail procedure was interrupted.Cardiac massage and other measures restarted the heartbeat, but the bleeding did not stop, so a vascular surgeon joined the search for the bleeding site but was unable to find it.Later, the bleeding was successfully stopped and the patient's condition stabilized.Patient was admitted to the general ward.The hospital speculates that the cause of the bleeding was either a vascular injury caused by the use of a passer, or a vascular injury caused by a retractor used at the time of wound opening.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Cable cerclage cable with crimp 1.8 mm dia.635 mm length item# 00223200418 lot# 66589245.Cable cerclage cable with crimp 1.8 mm dia.635 mm length item# 00223200418 lot# 66840314.Cable cerclage cable with crimp 1.8 mm dia.635 mm length item# 00223200418 lot# 66851906.Cable passer medium item# 00223200720 lot# unknown.Cable passer large item# 00223200730 lot# unknown.Unknown retractor item# unknown lot# unknown.G2.Report source: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined this mdr should not be filed under the current mfr number and should be voided.Reportability will continue under mfr number (b)(4).
Event or Problem Description
Upon reassessment of the reported event, it was determined this mdr should not be filed under the current mfr number and should be voided.Reportability will continue under mfr number (b)(4).

• Brand Name: CMN FEMORAL NAIL, CCD 125°, LEFT, ø 11.5 MM, 21.5 CM
• Common Device Name: IMPLANT, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER 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: 20894206
• Report Number: 0009613350-2024-00591
• Device Sequence Number: 21093162
• Product Code: HSB
• UDI-Device Identifier: 00889024298880
• UDI-Public: (01)00889024298880(17)340214(10)3196283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47249321111
• Device Lot Number: 3196283
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown