MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH CMN FEMORAL NAIL, CCD 125, LEFT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products - medical devices.Cmn femoral nail, ccd 130, left, 13 mm, 21.5 cm, item# 47249321313 , lot# 3096365.Report source - canada.Multiple mdr reports were filled for this event, please see associated reports: 0009613350 -2022 -00462.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.
Event or Problem 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.
Event or Problem Description
No further event information available at the time of this report.
Additional 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.

• Brand Name: CMN FEMORAL NAIL, CCD 125, LEFT, 13 MM, 21.5 CM
• Common Device Name: ZIMMER NATURAL NAIL
• 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 ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15368050
• Report Number: 0009613350-2022-00459
• Device Sequence Number: 1622878
• Product Code: HSB
• UDI-Device Identifier: 00889024298897
• UDI-Public: (01)00889024298897(17)320107(10)3096419
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-211-13
• Device Lot Number: 3096419
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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
• Patient Sex: Unknown