• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CORTICAL BONE SCREW, ÿ 4X28MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SWITZERLAND MANUFACTURING GMBH CORTICAL BONE SCREW, ÿ 4X28MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problem Material Integrity Problem (2978)
Patient Problem Joint Dislocation (2374)
Event Date 02/07/2022
Event Type  Injury  
Manufacturer Narrative
Medical product: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010653. Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3024714. Blunt tip screw, 4x60mm; catalog#: 47-2486-060-40; lot#: 3054546. Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538. The manufacturer received x-rays and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. 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. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4). The following reports are associated with this event: 0009613350-2022-00126; 0009613350-2022-00127; 0009613350-2022-00129.
 
Event Description
It was reported that operation was performed with ann nail system. After 4 months from the initial, surgeon found a screw of the proximal screws was backed out from the proper position. The surgeon keep an eye on the patient condition as well as no revision will be planned so far. Patient involvement. No further outcome.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCORTICAL BONE SCREW, ÿ 4X28MM
Type of DeviceAFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
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 Key13666846
MDR Text Key286570069
Report Number0009613350-2022-00128
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K200814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-128-40
Device Lot Number3068488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2021
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: 03/04/2022 Patient Sequence Number: 1
-
-