MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW REAMER, SHORT; TRAUMA, INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source france the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a lag screw reamer for cmn nail broke during primary surgery.A small piece was left and is still inside the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ZNN¿¢, CMN LAG SCREW REAMER, SHORT
• Type of Device: TRAUMA, INSTRUMENTS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18873645
• MDR Text Key: 337300057
• Report Number: 0009613350-2024-00090
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(11)230614(10)4504770497
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00249000364
• Device Lot Number: 4504770497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male