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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X44MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X44MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Insufficient Information (4580)
Event Date 06/25/2021
Event Type  Injury  
Manufacturer Narrative
Medical product: blunt tip screw, 4x65mm; item#47248606540; lot#3010693; blunt tip screw, 4x38mm; item#47248603840; lot#3064862; blunt tip screw, 4x36mm; item#47248603640; lot#3068457; proximal humerus, right, 11x160mm; item#47249616011; lot#3045138 cortical bone screw, 4x26mm; item# 47248612640; lot#3054456; cortical bone screw, 4x28mm; item#47248612840; lot#3054458; proximal humerus nail cap, 0mm; item#47248801000; lot#3073821 the manufacturer did not received x-rays or any other source documents for review. Lot numbers were received and the device history record were reviewed and found to be conforming. The investigation of the case and the process of gaining necessary information is still ongoing. 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
During the surgery, it was noticed by the surgeon that the screw was loose and couldn't be tightened.
 
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Brand NameBLUNT TIP SCREW, 4X44MM
Type of DeviceAFFIXUS(R) NATURAL NAIL(R) 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 Key12249253
MDR Text Key266169558
Report Number0009613350-2021-00357
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 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-044-40
Device Lot Number3010652
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/31/2019
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: 07/29/2021 Patient Sequence Number: 1
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