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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130A LEFT, 10 MM, 32 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130A LEFT, 10 MM, 32 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Insufficient Information (3190)
Patient Problem Ossification (1428)
Event Date 05/27/2021
Event Type  Injury  
Manufacturer Narrative
Investigation results were made available. Event description: it was reported that on (b)(6) 2019, the patient was fixed with an intramedullary nail for a fracture. On (b)(6) 2021, the patient underwent surgery to remove the intramedullary nail, and intraoperatively, the end caps of the screws were found to be covered with bone scabs. The surgeon made several attempts to remove the intramedullary nail without success. Hence, the internal fixation was not removed due to the risk of re-fracture. 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. As additional information becomes available, the complaint will be reinvestigated accordingly. Product evaluation: the products remain implanted. Review of product documentation: device purpose: all involved devices are intended for treatment. Product compatibility: the product combination was approved by zimmer biomet. Dhr review: review of the device history records (of the nail and the lag screw) identified no deviations or anomalies during manufacturing. Conclusion: it was reported that on (b)(6) 2019, the patient was fixed with an intramedullary nail for a fracture. On (b)(6) 2021, the patient underwent surgery to remove the intramedullary nail, and intraoperatively, the end caps of the screws were found to be covered with bone scabs. The surgeon made several attempts to remove the intramedullary nail without success. Hence, the internal fixation was not removed due to the risk of re-fracture. 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). Due to a lack of medical records such as radiographs and surgical reports, the reported event could not be investigated. Therefore, the reported event could not be confirmed based on the available information. The need for corrective measures is not indicated and zimmer (b)(4) manufacturing gmbh considers this case as closed. Zimmer biomet's reference number of this file is (b)(4). The following reports are associated with this event: 0009613350-2021-00365.
 
Event Description
It was reported that during revision surgery the implants could not be removed and therefore remained in patient.
 
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Brand NameCMN FEMORAL NAIL, CCD 130A LEFT, 10 MM, 32 CM
Type of DeviceZIMMER 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 Key12252724
MDR Text Key264292446
Report Number0009613350-2021-00366
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-323-10
Device Lot Number2966487
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/30/2021 Patient Sequence Number: 1
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