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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULRICH MEDICAL USA MOMENTUM SCREWDRIVER FOR POLYAXIAL SCREW

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ULRICH MEDICAL USA MOMENTUM SCREWDRIVER FOR POLYAXIAL SCREW Back to Search Results
Model Number UU052-30-0100
Device Problems Material Fragmentation (1261); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
A screwdriver tip broke off during surgery. There was no effect on the patient.
 
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Brand NameMOMENTUM
Type of DeviceSCREWDRIVER FOR POLYAXIAL SCREW
Manufacturer (Section D)
ULRICH MEDICAL USA
18221 edison ave.
chesterfield MO 63005
Manufacturer (Section G)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM 89081
Manufacturer Contact
louis milos
18221 edison ave.
chesterfield, MO 63005
MDR Report Key14337031
MDR Text Key291818879
Report Number3005823819-2022-00013
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00814386025010
UDI-Public00814386025010
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUU052-30-0100
Device Catalogue NumberUU052-30-0100
Device Lot NumberU025561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
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