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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments of the 61152-100 drill were inspected and showed no deviations.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.As a result of the above and the fact that no device was returned for evaluation and further information is missing, this complaint is deemed unconfirmed.Device was used for thumb repair.The drill was roughly a quarter of the way in the bone when the surgeon told the drill bit had broke.The break was clean and both pieces were retrieved from the patient.Following this incident, dr (b)(6) used a competitors hcs set for the remainder of the case.The competitors set was readily available and there was no delay to the surgery.
Event or Problem Description
It was reported that a cannulated drill broke intra-operatively.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: 9450365
• Report Number: 3004369035-2019-00015
• Device Sequence Number: 3103931
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: 61152-100
• Device Catalogue Number: 61152-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention