MAUDE Adverse Event Report: I.T.S. GMBH SPIRAL DRILL, CANNULATED, D=1.75MM/D=1.0MM, L=100MM

Model Number 61175-100

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

We have inspected the dhf and no deviation was detected.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for scaphoid fixation treatment.<30 min delay to remove the fractured drill part.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during surgery, the drill bit fractured inside the patient.Original implant date (b)(6) 2019.

• Brand Name: SPIRAL DRILL, CANNULATED, D=1.75MM/D=1.0MM, L=100MM
• Type of Device: SPIRAL DRILL, CANNULATED, D=1.75MM/D=1.0MM, L=100MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 9339689
• MDR Text Key: 214821156
• Report Number: 3004369035-2019-00014
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 09120047301135
• UDI-Public: 09120047301135
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61175-100
• Device Catalogue Number: 61175-100
• Device Lot Number: 26/F44273
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention