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

Model Number	UU052-30-0500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: MOMENTUM
• Common Device Name: SCREWDRIVER FOR LOCKING SCREW
• Manufacturer (Section D): ULRICH MEDICAL USA; 18221 edison ave.; chesterfield, mo
• MDR Report Key: 10279658
• Report Number: 3005823819-2020-00012
• Device Sequence Number: 11473635
• Product Code: NKB
• UDI-Device Identifier: 00814386025072
• UDI-Public: 00814386025072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UU052-30-0500
• Device Catalogue Number: UU052-30-0500
• Device Lot Number: VM421052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization