MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 11.5 MM, 21.5 CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: znn, cmn lag screw¸ 10.5 mm, 115 mm including set screw.Item #47248511510, lot# 3093322, 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, item# 47248403250, lot# 65613735 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, item# 47248404550 lot# 65378233 report source¿ foreign ¿ ¿france" multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00143 investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent a procedure for a pertrochanteric fracture with a nail.Post-op x-rays showed the cervical screw and the two distal screws had passed above the nail, and not passed through the holes provided in the nail.The nail was removed and replaced.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
Upon review of this complaint from an investigation perspective, it is now confirmed that the event doesn't represent a serious injury and is not related to product malfunction which has led to a serious injury event will be non -reportable and report will be voided.
Event or Problem Description
It was reported that: an intra-op assembly issue occurred during the op.The cervical screw and the 2 distal screws had passed above the nail and not in the holes provided for this purpose.The nail was removed then replaced with another zimmer nail with another ancillary.The event was evaluated as non-reportable during the investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical documents in the form of surgical report and implant labels were provided and reviewed by hcp: findings: general anesthesia sub-trochanteric approach placement of the cephalic pin in the center of the head, in the center of the neck.Measurement at the 115m borehole length.Insertion of a cervical screw length 115 and two distal screws using the automatic ancillary, the cephalic sensation, the nail and its guide goes up outside the patient, the cephalic screw having passed in front of the nail and not inside of it.C-arm check for placement of nail and screws, the cervical screw and the 2 distal screws had been passed over the nail, and not through the holes provided for this purpose all components exchanged.He (surgeon) asked that this malfunctioning c-arm be assessed and the arch be appraised (on later clarification, it was discovered that the surgeon was referring to the targeting guide and not to the c-arm fluoroscopy system) significant increase in surgical time.Based on the given information and results of the investigation, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CMN FEMORAL NAIL, CCD 125°, RIGHT, ø 11.5 MM, 21.5 CM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 16767719
• Report Number: 0009613350-2023-00141
• Device Sequence Number: 16956891
• Product Code: HSB
• UDI-Device Identifier: 00889024298842
• UDI-Public: (01)00889024298842(17)330130(10)3143338
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 08/10/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47249321011
• Device Lot Number: 3143338
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 07/12/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 08/08/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male