MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130°, RIGHT, 11.5 MM, 34 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Human-Device Interface Problem (2949)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Insufficient Information (4580)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that: explant of the nail after the patient fell on the floor.Patient outcome - revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The raw material certificate was reviewed with no anomalies noted.It was reported that the patient had a fall event prior to the revision.If and to what extent the fall event caused or contributed to the revision surgery remains unknown.It can be assumed that due to the fall event, the patient suffered an implant fracture and a re-fracture of the bone.However, due to a lack of information, 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.

Event Description

No further event information available at the time of this report.

• Brand Name: CMN FEMORAL NAIL, CCD 130°, RIGHT, 11.5 MM, 34 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY 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: 14307852
• MDR Text Key: 290923956
• Report Number: 0009613350-2022-00271
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024299504
• UDI-Public: 00889024299504
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-342-11
• Device Lot Number: 3020706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization