MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UCENTUM; SCREWDRIVER, OPEN, CANNULATED, HEX 3.5MM

Model Number CS 3825-01

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Screwdriver tip broke off while in surgery, was not able to be retrieved, and remains in the patient.

• Brand Name: UCENTUM
• Type of Device: SCREWDRIVER, OPEN, CANNULATED, HEX 3.5MM
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, 89081 ; GM 89081
• Manufacturer Contact: christoph ulrich ; buchrunnenweg 12; ulm, 89081 ; GM 89081 ; 7319654 16
• MDR Report Key: 6135004
• MDR Text Key: 61191231
• Report Number: 9612420-2016-00014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04052536081202
• UDI-Public: 4052536081202
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K123717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS 3825-01
• Device Catalogue Number: CS 3825-01
• Device Lot Number: U003811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2016
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization