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.

Manufacturer Narrative

D10: medical products: znn cmn lag screw, 10.5 mm, 90 mm, including set screw; catalog#: 47-2485-090-10; lot#: 2927604.Therapy date: unknown.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information which was received on aug 16, 2021.Additional: b5, b7, d8, d10, h6.Correction: b4, d4, d5, e1, g2, g3, g6, h2, h3, h8, h10.The manufacturer received x-rays and other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

During the explantation of the metal nails it was found that the patient's callus was covered with the screw tail cap.The intermedullary nail could not be removed and was left inside the patient.The surgeon used the standard lag screw removal tool, but the tail was broken off and he had to give up.The surgery began at 9am and ended at 2-3pm.

Manufacturer Narrative

1.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.And it was reported that during surgery the cams (tail) of the lag screw broke.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.Harm: s2 - tissue damage, minor hazardous situation: user cannot remove existing and well-fixed implants during a medical or surgical intervention.2.Review of received data: - one intraoperative radiography from (b)(6) 2021 was received.The radiography is of poor quality due to the low contrast.The reported event cannot be verified based on the provided intra-operative image with certainty.- otherwise, 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 re-investigated accordingly.3.Product evaluation: - the products remain implanted.4.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.5.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.And it was reported that during surgery the cams (tail) of the lag screw broke.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 non-conformance or a complaint out of box (coob).The correct removal of the lag screw is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique (b)(4).It was reported that the devices remain in the patient.There are possible causes for the breakage of the cams of the lag screw during the removal of the znn nailing system: ¿ if the contact surface of the instrument and implant is too small, too high forces will be transmitted on the cams which lead to a fracture of this section.¿ excessive bone ingrowth onto the lag screw due to long in vivo time of the implant system, which makes high forces needed to remove the screw in a removal case.¿ pathogenic bone diseases (e.G.Bone tumor) which affect mechanical properties of the bone (harder/ denser bone substance).Based on the available information, an exact root cause could not be determined.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).The following reports are associated with this event: 0009613350-2021-00365.

Event Description

New information received.Investigation was updated.

• 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
• 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
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-323-10
• Device Lot Number: 2966487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 27 YR