MAUDE Adverse Event Report: IMPLANTCAST GMBH DRILLING PIN 3,2MM X 77MM

Model Number 42240132

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

The suspected medical device drilling pin 3,2mm x 77mm is not listed/approved in the us, but is similar to the following devices listed/approved in the us: drilling pin 2,5mm x 77mm, drilling pin 2,5mm x 97 mm.The suspected medical device drill pin is not listed/approved in the us, but is similar to the following devices listed/approved in the us: drilling pin 2,5mm x 77mm, drilling pin 2,5mm x 97 mm.For the optical inspection the affected product was not available for the analysis.No review of the product and manufacturing documentation could be performed because the lot of the product was unknown.The content of the surgical technique and the instructions for use have been checked, and no faults were found.A technical cause for the fracture cannot be determined on the basis of the information.

Event Description

During an operation, a drill bit broke in a pin adapter.After consultation with the surgeon, this had no effect on patients, users or third parties.

• Brand Name: DRILLING PIN 3,2MM X 77MM
• Type of Device: DRILLING PIN 3,2MM X 77MM
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• MDR Report Key: 18334575
• MDR Text Key: 330596780
• Report Number: 3012523063-2023-00019
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: LE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42240132
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IC-PIN-ADAPTER, REF: (B)(4).