MAUDE Adverse Event Report: I.T.S. GMBH SPIRAL DRILL, CANNULATED, D=1.5MM/D=1.0MM, L=100MM

Model Number	61152-100
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the qc documents of the last three batches of the affected device shipped to the distributor and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.The drill was used for a fixation of the distal phalanx of the toe and no sleeve or additional instrumentation was used.According to the reps statement, the angle/torque was not changed by the surgeon during the surgery.The surgeon fixed three toes simultaneously and on the third the drill broke.
Event or Problem Description
It was reported that a cannulated drill broke intraoperatively.Original surgery time unkown.No delay in surgery.

• Brand Name: SPIRAL DRILL, CANNULATED, D=1.5MM/D=1.0MM, L=100MM
• Common Device Name: SPIRAL DRILL, CANNULATED, D=1.5MM/D=1.0MM, L=100MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 9645902
• Report Number: 3004369035-2020-00001
• Device Sequence Number: 2768463
• Product Code: HTW
• UDI-Device Identifier: 09120047301128
• UDI-Public: 09120047301128
• 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): 01/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 61152-100
• Device Catalogue Number: 61152-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other