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

Model Number UU052-30-0100

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

Event Description

Screwdriver broke at the tip.

• Brand Name: MOMENTUM
• Type of Device: SCREWDRIVER FOR POLYAXIAL SCREW
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-wurttemberg 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 17890044
• MDR Text Key: 325141911
• Report Number: 3005823819-2023-00009
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00814386025010
• UDI-Public: 00814386025010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UU052-30-0100
• Device Catalogue Number: UU052-30-0100
• Device Lot Number: U028211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR