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

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: cmn femoral nail, ccd 130, left, 10 mm, 21.5 cm; catalog#: 47-2493-213-10; lot#: 3036453.Therapy date: (b)(6) 2021.The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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 there was a fracture of the "wings" at me of the femoral neck screw.Op time extension by approx.120-150min.

Event Description

Investigation results are now available.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The device has been received for investigation.Event happened in germany.Investigation results are now available.Investigation and conclusion: 1.Event description: it was reported that the wings of the lag screw were fractured during the removal process.Surgery delay 120 - 150min.Harm: s3 - instability, moderate.Hazardous situation: implant breaks or becomes damaged and non-functional during surgical procedure, but is replaced intraoperatively before completing implantation.2.Review of received data: no medical data (like surgical reports or x-rays) 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.3.Product evaluation: visual examination: the lag screw and nail were returned for investigation.The visual examination shows that the lag screw wings were completely fractured.In addition, there are circular marks visible on shaft area of the lag screw.The nail shows also some damages and deformations on the hole for the lag screw.This can be caused during the implantation or while trying to remove the lag screw.4.Review of product documentation: device purpose: all involved devices are intended for treatment.The product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Surgical technique sap: surgical technique: the correct lag screw placement/removal is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.Complaint history review: 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.5.Conclusion: it was reported that the wings of the lag screw were fractured during the removal process.Surgery delay 120 - 150min.No x-rays or medical records were received.The investigation did not identify a nonconformance or a complaint out of box (coob).It is assumed that the wings were broken/cracked due to an overload.Possible causes for the overload could be: unfavorable placement between the instrument and the implant so their contact surface is too small, too high forces will be transmitted on the flanks which lead to a fracture/crack of this section.Pathogenic bone diseases (e.G.Bone tumor) which can affect mechanical properties of the bone (harder/ denser bone substance).This could also lead to higher forces of these sections.However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Zimmer reference: (b)(4).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW
• Type of Device: ZIMMER NATURAL NAIL SYS.CEPHALOMEDULLARY
• 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: 13305549
• MDR Text Key: 284102039
• Report Number: 0009613350-2022-00035
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298446
• UDI-Public: 00889024298446
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-095-10
• Device Lot Number: 3026039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2020
• 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): Hospitalization; Required Intervention