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

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.

Manufacturer Narrative

An mdr was submitted on precedent after a complaint was received alleging that a screwdriver tip had broken off during surgery.When the part was returned, we found it intact and working properly.Mdr was not warranted.

• 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
• MDR Report Key: 14337031
• MDR Text Key: 291818879
• Report Number: 3005823819-2022-00013
• 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,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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: U025561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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 Sex: Female