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	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the dhf of the affected lot and including material certificate and hardness test certificate and the affected batch was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.As soon we receive the affected product back, we will initiate further investigation.The device was used to drill in the p3 base into sclerotic bone for fixation with a hcs screw.Surgery was finalized with a competitors product.The adverse event caused an approx.20 min delay in surgery.
Event or Problem Description
It was reported that a cannulated drill broke intra-operatively at p3 base in sclerotic bone.This is report 2/2.

• 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
• 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: 13629956
• Report Number: 3004369035-2022-00334
• Device Sequence Number: 19838299
• Product Code: HTW
• UDI-Device Identifier: 09120047301128
• UDI-Public: 09120047301128
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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
• Device Lot Number: 855/336327
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Unknown