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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 0.5 MM, 105 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH ZNN, CMN LAG SCREW, 0.5 MM, 105 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information was received on aug 28, 2017. During the investigation it was found out that the issue (sizing) is related to the guide pin and targeting guide. Therefore, 2 more reports are submitted for this complaint. One is for the guide pin and one is for targeting guide. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. During the trend analysis no trend was identified. Event summary: the guide pin got stuck in the guide before insertion of the screw in the patient. The surgeon used another cannula from a different system. When that happened, the measurement for the lag screw was thrown off. The surgeon held up the screw against the patient's x-ray and saw that the screw would be too small for the patient. To resolve the issue, the surgeon used a bigger screw. No medical data such as x-rays, surgical notes or any other case-relevant documents received. Devices analysis: visual examination :for product investigation only the lag screw was returned. The guide pin or the targeting guide have not been returned for evaluation. No information provided about reference and lot numbers. The returned lag screw is new and unused. No signs of any damages or deformations. Measurements were done on the lag screw. All measurements were within the required specifications. Review of product documentation: the correct lag screw placement is described in the surgical technique 97-2493-002-00 on page 7. ". Remove the trocar and insert the 3. 2mm lag screw pin sleeve. Insert a pin through the pin sleeve. Under fluoroscopy, drill the pin to the level of the subchondral bone of the femoral head without penetrating the femoral cortex. Assess the position of the pin using the c-arm in the a/p and lateral planes. If the pin is appropriately placed, proceed with the next steps. If the pin is not appropriately placed, remove it, adjust the guide under fluoroscopy and replace the pin correctly. Remove the 3. 2mm lag screw pin sleeve from the lag screw cannula. Slide the cannulated lag screw depth gauge over the pin down to the bone. Confirm that the depth gauge is touching the lateral cortex of the femur using fluoroscopy to accurately determine the length of lag screw to be used. The end of the pin in the depth gauge indicates the length of lag screw to be used. " root cause analysis a root cause analysis cannot be done as no information was provided for the seizing of the guide pin and targeting guide. No reference number and lot numbers received. Therefore, it is unknown how the seizing was occurred and on which specific instruments. The guide pin and targeting guide have not been returned for evaluation. Conclusion summary it was reported that the guide pin got stuck in the guide. The surgeon used another cannula from a different system to complete the surgery. During the x-ray control the surgeon saw that the lag screw would be too small for the patient. To resolve the issue, the surgeon used a bigger lag screw. The guide pin and targeting device have not been returned. Only the lag screw was returned. In the surgical technique 97-2493-002-00 it is described how to place the guide pin correctly. If the pin is not appropriately placed, remove it, adjust the guide under fluoroscopy and replace the pin correctly. Afterwards, the cannulated lag screw depth gauge has be used to determine the correct length of the lag screw. The returned lag screw was visually inspected. The lag screw is unused. No signs of deformations or damages. A measurement was also done. All performed measurements were within the required specifications. As no specific information were provided about the seizing of the guide pin and targeting guide, no detailed investigation can be done. For the lag screw no malfunction was reported. The lag screw was only returned as the surgeon was not able to use the lag screw depth gauge to measure the correct length which was needed for the patient. Under x-ray control he realized that the lag screw was to short and used a bigger one. Based on the given information and performed investigation, it cannot be said, why the guide pin got stuck. The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).
 
Manufacturer Narrative
The manufacturer did not receive devices, x-rays, or other source documents for review. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. (b)(4).
 
Event Description
It was reported that during surgery the guide pin got stuck in the guide before insertion of the screw in the patient. The surgeon used another cannula from a different system. When that happened, the measurement for the lag screw was thrown off. The surgeon held up the screw against the patient's x-ray and saw that the screw would be too small for the patient. To resolve the issue, the surgeon used a bigger screw. Additional information has been requested and is not currently available.
 
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Brand NameZNN, CMN LAG SCREW, 0.5 MM, 105 MM INCLUDING SET SCREW
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
kevin escapule
1800 west center street
warsaw, IN 46580
8006136131
MDR Report Key6574948
MDR Text Key253558353
Report Number0009613350-2017-00661
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Model NumberN/A
Device Catalogue Number47-2485-105-10
Device Lot Number2858448
Other Device ID Number00889024298460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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