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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH SET SCREW, 8 MM, 21 MM, HEX 3.5 MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH SET SCREW, 8 MM, 21 MM, HEX 3.5 MM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem Failure of Implant (1924)
Event Date 06/08/2017
Event Type  Injury  
Manufacturer Narrative
As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive more information for this case. The missing information was requested at complainant the latest one on (b)(6) 2017 but was not available. A technical investigation was not possible to perform, as the device(s) were not at hand for investigation. Device history records (dhr) as no lot numbers were provided for the devices, the device history records could not be reviewed. The missing device information has been requested but was not available. At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures. Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold. These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors. Thus, for all products sold to the market can be assumed having a complete and correct dhr. Trend analysis: no trend considering the following event is identified: difficulties to remove the set screw. Review of event description: it was reported that it was impossible to remove the set screw, therefore it was also not possible to remove all the implants. Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received. Devices analysis: no product was returned to zimmer biomet for in-depth analysis. Review of product documentation: the removal of the znn nailing system is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique 97-2493-002-00. This surgical technique describes that the use of a nail cap to close the proximal part of the nail to prevent bone ingrowth is recommended. The set screw extraction is described on page 26: "remove the screws using a 3. 5 mm hex screw driver. Remove the nail cap (if one was inserted) with a 5. 0 mm hex screw driver. Use a 3. 5 mm hex screw driver to remove the set screw. " root cause determination using rmw: damage of the implant (set screw) due to lack of adequate set screws design for insertion and extraction.
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> not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment. Damage of the implant (hex-stripping) due to lack of adequate nail cap and set screws design for extraction.
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> not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment. Failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system.
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> possible, it is possible that the user did not use the appropriate screwdriver to remove the set screw and was therefore not able to remove the set screw. Failure of surgery due to missing/incomplete information available, misleading information of surgical technique and/or instructions for use.
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> not possible -> no issue identified with the surgical technique and/or instructions for use. Conclusion summary: it was reported that it was impossible to remove the set screw, therefore it was also not possible to remove all the implants. No devices have been returned to zimmer biomet for in-depth analysis. However, it is unknown when the znn nailing system was implanted. Therefore, the in vivo time until this event occurred is unknown. There are two most possible factors which may have contributed to the reported event. If no nail cap was implanted, it can be assumed that there was bone ingrowth in the proximal part of the nail where the set screw was inserted. It is possible that the bone ingrowth did not allow to remove the set screw. No information was provided if a nail cap was used to prevent bone ingrowth as described in the surgical technique. Another possibility is that the user did not use the appropriate screwdriver to remove the set screw and was therefore not able to remove the set screw. However, an exact root cause for the reported event could not be determined. The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed. Zimmer biomet's reference number of this file is (b)(4).
 
Event Description
It was reported that it was impossible to remove the znn cmn set screw during surgery, therefore it was also not possible to remove the implant. Due to this, an involuntary retain of the device in the patient was "forced".
 
Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. Additional information has been requested and is currently not available. 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 the patient was implanted a unknown znn cmn trauma screw on an unknown date and the patient underwent revision surgery on (b)(6) 2017 due to unknown reason. It was also reported that it was impossible to remove the locking screw, therefore it was also not possible to remove the implant. Due to this, an involuntary retain of the device in the patient was "forced".
 
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Brand NameSET SCREW, 8 MM, 21 MM, HEX 3.5 MM
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6950767
MDR Text Key113553913
Report Number0009613350-2017-01443
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-000-00
Device Lot NumberUNKOWN
Other Device ID Number00889024298620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/16/2017 Patient Sequence Number: 1
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