MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREWDRIVER

Model Number CS 33825-01

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

A previous mdr has been filed on the same product number tip breaking off.We attempted to investigate whether the tip broke off inside the patient and had to be removed or if it broke outside the patient and did not affect surgery.We have reached out and talked to the distributor but were not able to get a definitive answer on what happened, thus we are reporting as if the tip broke off in the patient.

Event Description

We received a complaint that the screwdriver had sheared off during the case.When the product was received back we discovered the tip had broken off.

• Brand Name: UCENTUM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; na; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchbrunnenweg 12; na; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 9124031
• MDR Text Key: 189352221
• Report Number: 9612420-2019-00051
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536081202
• UDI-Public: 4052536081202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CS 33825-01
• Device Catalogue Number: CS 3825-01
• Device Lot Number: U003811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No
• 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