MAUDE Adverse Event Report: ZIMMER GMBH KIRSCHNER WIRE WITH DOUBLE TROCAR TIP, ø 1.8 MM, 310 MM; INSTRUMENT, EXTREMITIES

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that during an osteosynthesis, the kirschner wire broke in the patient's bone.Broken device not removed from patient's scapula.Risk of infection.Intervention continued.Favorable outcome following the surgery, satisfactory x-rays and scanner radiography control with good reduction of the fracture.Broken part of wire available to be returned.Diligence is complete and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).G2.Report source: france.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: KIRSCHNER WIRE WITH DOUBLE TROCAR TIP, ø 1.8 MM, 310 MM
• Type of Device: INSTRUMENT, EXTREMITIES
• 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: 18924478
• MDR Text Key: 337918621
• Report Number: 0009613350-2024-00103
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 29118310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Male