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 12/14/2020

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.No product was available for the analysis.The drill used is very filigree at 2.0mm.During drilling, it is guided through the drill sleeve or the drilling template.For an unknown reason, the drill bit may have jammed, which then probably broke during further feed.Removal of the drill would have resulted in disproportionate damage to the bone.As a result, a part of the broken drill was left in 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 content of the surgical technique and the instructions for use have been checked, and no faults were found.The occurrence rate is below the accepted threshold.

Event Description

The following event was reported to implantcast gmbh: "the drill bit broke off during drilling and the tip of the drill bit remained in the bone.".

• 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, lower saxony 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude; lower saxony, 21614 ; GM
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude; lower saxony 21614
• MDR Report Key: 18334431
• MDR Text Key: 330595321
• Report Number: 3012523063-2023-00016
• 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: 16451FE10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• 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: DRILL GUIDE FOR GLENOID CEMENTLESS, REF:77101104
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 85 KG