MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH CMN FEMORAL NAIL, CCD 130, LEFT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM

Model Number N/A

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that when the sterile package was opened by removing paper peel, it was observed glue and paper residue remained on the inner side of the packaging.The surgery was completed with another the same product with no health consequences and delay.Attempts have been made and no further information has been provided yet.

Manufacturer Narrative

(b)(4).Concomitant medical products - medical devices.Cmn femoral nail, ccd 125, left,13 mm, 21.5 cm , item# 47249321113 , lot# 3096419.Report source - canada.Multiple mdr reports were filled for this event, please see associated reports: 0009613350 -2022 -00459.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned.Visual examination of the provided pictures identified evidence of adhesive residue on seal surface of blister.This is considered to be a cosmetic issue with no adverse impact to product sterility.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.The root cause of the reported issue is attributed to adhesive residue remaining on seal surface of blister on removal of tyvek lid.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, LEFT, 13 MM, 21.5 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM
• Manufacturer (Section D): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15368066
• MDR Text Key: 302777558
• Report Number: 0009613350-2022-00462
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298972
• UDI-Public: (01)00889024298972(17)320201(10)3096365
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-213-13
• Device Lot Number: 3096365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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