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

Model Number UU052-30-0100

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

No information has been received to indicate harm to the patient, but this malfunction has been filed as a serious injury mdr in the past.

Event Description

A screwdriver was received back with the tip broken off.No complaint was reported, no additional information available.

• Brand Name: MOMENTUM
• Type of Device: SCREWDRIVER 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 ; 6365190268
• MDR Report Key: 11083206
• MDR Text Key: 262964056
• Report Number: 3005823819-2020-00024
• 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: 12/28/2020

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
• Device Operator: Health Professional
• Device Model Number: UU052-30-0100
• Device Catalogue Number: UU052-30-0100
• Device Lot Number: U027157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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