MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was noticed that the packaging was damaged and sterility was not given anymore.
Additional 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).
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the implant packaging of item# 47248509510 was found compromised and no longer sterile.There was no patient involvement.Review of received data: no medical data relevant to the case has been received.Due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the visual examination confirms the reported event of packaging damage.However, contrary to the reported event, not the primary packaging but the secondary packaging is damaged.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Conclusion: it was reported that the implant packaging of item# 47248509510 was found compromised and no longer sterile.There was no patient involvement.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the investigation the reported event of packaging damage can be confirmed.However, contrary to the reported event, not the primary packaging but the secondary (outer) packaging is damaged.Therefore it can be concluded that a wrong handling or transportation issue of the device has most likely led to the damaged packaging.Furthermore, there are no other complaints for this item number nor for the same lot number.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.However, the most likely root cause for the reported error pattern is damage during transport/storage.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW
• Common Device Name: 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: 13498167
• Report Number: 0009613350-2022-00062
• Device Sequence Number: 20009908
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: 00889024298446
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-095-10
• Device Lot Number: 3083707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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