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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X40MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X40MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  Injury  
Manufacturer Narrative
Investigation of this incident is currently ongoing. A followup/ final report will be submitted when additional information becomes available. Zimmer reference: (b)(4). Concomitant medical products: blunt tip screw, 4x50mm catalog: 47-2486-050-40 lot: 3024741. Blunt tip screw, 4x65mm catalog: 47-2486-065-40 lot: 3039406. Cortical bone screw, 4x24mm catalog: 47-2486-124-40 lot: 3078234. Cortical bone screw, 4x26mm catalog: 47-2486-126-40 lot: 3078193. Proximal humerus nail cap, 10. 5x5mm catalog: 47-2488-010-05 lot: 3068499. Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00256, 0009613350-2022-00260, 0009613350-2022-00261.
 
Event Description
It was reported that 5 weeks after initial surgery, one of the proximal screws had backed out from the proper position. The surgeon is keeping an eye on the patient condition. No revision surgery will be planned so far. Attempts have been made and no further information has been provided.
 
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Brand NameBLUNT TIP SCREW, 4X40MM
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 Key14237481
MDR Text Key290289462
Report Number0009613350-2022-00257
Device Sequence Number1
Product Code HSB
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-040-40
Device Lot Number3073746
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2021
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: 04/28/2022 Patient Sequence Number: 1
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