• 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 MANFACTURING GMBH BLUNT TIP SCREW, 4X48MM AFFIXUS(R) NATURAL NAIL(R) 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 MANFACTURING GMBH BLUNT TIP SCREW, 4X48MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: medical product: proximal humerus, left, 11x160mm; catalog#: 47-2496-161-11; lot#: 3059714. Blunt tip screw, 4x44mm catalog #:47-2486-044-40; lot #: 3010657. Blunt tip screw, 4x46mm; catalog #: 47-2486-046-40; lot#: 3039376. Blunt tip screw, 4x52mm; catalog#: 47-2486-052-40; lot#: 3054392. Blunt tip screw, 4x54mm; catalog#: 47-2486-054-40; lot#: 3054549. Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40 ; lot#: 3076797. Cortical bone screw, 4x30mm; catalog#: 47-2486-130-40 ; lot#: 3073753. The manufacturer did not receive x-rays, or other source documents for review. The lot number of the device was received. The device history records will be reviewed during investigation. 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: 0009613350-2022-00243; 0009613350-2022-00244; 0009613350-2022-00245. Remains implanted.
 
Event Description
It was reported that operation was performed with nail. After 2 month from the initial, surgeon found #1 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBLUNT TIP SCREW, 4X48MM
Type of DeviceAFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
Manufacturer (Section D)
ZIMMER SWITZERLAND MANFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANFACTURING 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 Key14141249
MDR Text Key289498474
Report Number0009613350-2022-00246
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024505483
UDI-Public00889024505483
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181827
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 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-048-40
Device Lot Number3024731
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2020
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: 04/19/2022 Patient Sequence Number: 1
-
-