MAUDE Adverse Event Report: IMPLANTCAST GMBH DRILL A/O CHUCK 2,0 MM

Model Number 77000020

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

The suspected medical device drill a/o chuck 2,0 mm is not listed/approved in the us, but is similar to the following devices listed/approved in the us: drill 2,5 mm ao.During preparation of an implant, the drill broke off.The broken off end of the drill got stuck so deep in the bone that it could not be removed.The drill which is used is very filigree at 2.0mm.It is guided through the drilling template during drilling.For an unexplained reason, the drill may have jammed and then probably broken during further feed.Removal of the drill would have resulted in severe damage to the bone.After a review of the product and manufacturing documentation, a technical cause that could be due to design or manufacturing problems can be ruled out.The surgical technique and instructions for use have been checked and no errors were found.The occurrence rate is below the accepted threshold.

Event Description

The following event was reported to implantcast gmbh: "the drill bit 2.0mm broke off during drilling through the drill template for glenoid cementless and the above glenoid deep in the bone and could not be recovered.".

• Brand Name: DRILL A/O CHUCK 2,0 MM
• Type of Device: DRILL A/O CHUCK 2,0 MM
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 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: 18334511
• MDR Text Key: 330596062
• Report Number: 3012523063-2023-00017
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 77000020
• Device Lot Number: 16451FE37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GLENOID CEMENTLESS SIZE 3 ROUND, REF:38004001
• Patient Outcome(s): Required Intervention