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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X34MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X34MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Manufacturer Narrative
Medical product: proximal humerus, left, 7x160mm; item# : 47249616107; lot# : 3033560, blunt tip screw, 4x38mm; item# : 47248603840; lot# : 3024666, blunt tip screw, 4x56mm; item# : 47248605640; lot# : 3039378, cortical bone screw, 4x24mm; item# : 47248612440; lot# : 3039388, proximal humerus nail cap, 0mm; item# : 47248801000; lot# : 3039755, cortical bone screw, 4x24mm; item# : 47248612440; lot# : 3038358. Therapy date: unknown. The manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. 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).
 
Event Description
Patient was implanted on an unknown side. After 6 weeks from the surgery the proximal screw get loose and out the nail damaging arm soft tissues. No revision surgery was performed.
 
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Brand NameBLUNT TIP SCREW, 4X34MM
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 Key12049026
MDR Text Key263382140
Report Number0009613350-2021-00306
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCI
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 Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-034-40
Device Lot Number3010622
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 Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2020
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: 06/23/2021 Patient Sequence Number: 1
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