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U.S. Department of Health and Human Services

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

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ULRICH MEDICAL USA MOMENTUM; SCREWDRIVER FOR LOCKING SCREW Back to Search Results
Model Number UU052-30-0500
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/18/2020
Event Type  malfunction  
Event Description
A screwdriver tip broke off during surgery due to not using the torque limiting handle and overtightening the screw.The screwdriver tip was lodged in the screw so the screw and rod had to be removed to retrieve the tip.
 
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Brand Name
MOMENTUM
Type of Device
SCREWDRIVER FOR LOCKING SCREW
Manufacturer (Section D)
ULRICH MEDICAL USA
18221 edison ave.
chesterfield, mo
Manufacturer (Section G)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, baden-wurttemberg 89081
GM   89081
Manufacturer Contact
louis milos
18221 edison ave.
chesterfield, mo 
MDR Report Key10279658
MDR Text Key200423495
Report Number3005823819-2020-00012
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00814386025072
UDI-Public00814386025072
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
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUU052-30-0500
Device Catalogue NumberUU052-30-0500
Device Lot NumberVM421052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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