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

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.

• Brand Name: CMN FEMORAL NAIL, CCD 130A LEFT, 10 MM, 32 CM
• Type of Device: 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: 12252724
• MDR Text Key: 264292446
• Report Number: 0009613350-2021-00366
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• 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 Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2493-323-10
• Device Lot Number: 2966487
• 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 Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

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