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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW REAMER, SHORT; TRAUMA, INSTRUMENTS

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ZIMMER GMBH ZNN¿¢, CMN LAG SCREW REAMER, SHORT; TRAUMA, INSTRUMENTS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/10/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).G2: report source france the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that a lag screw reamer for cmn nail broke during primary surgery.A small piece was left and is still inside the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand Name
ZNN¿¢, CMN LAG SCREW REAMER, SHORT
Type of Device
TRAUMA, INSTRUMENTS
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER 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 Key18873645
MDR Text Key337300057
Report Number0009613350-2024-00090
Device Sequence Number1
Product Code HTO
UDI-Device Identifier00889024276260
UDI-Public(01)00889024276260(11)230614(10)4504770497
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00249000364
Device Lot Number4504770497
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/13/2024
Initial Date FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
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