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

Model Number	61175-100
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 9339689
• Report Number: 3004369035-2019-00014
• Device Sequence Number: 382370
• Product Code: HTW
• UDI-Device Identifier: 09120047301135
• UDI-Public: 09120047301135
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: 61175-100
• Device Catalogue Number: 61175-100
• Device Lot Number: 26/F44273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention