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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cannulated drill broke during surgery.There were no delays in surgery.Device was used for treatment, not diagnosis.
Additional Manufacturer Narrative
We have inspected the dhf of the affected lot including material certificate and the 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.The surgeon mentioned that the patient had real hard bone, which most likely caused the breakage, as no deviations were detected.Based on the information available, it has been determined that no corrective and preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 17017768
• Report Number: 3004369035-2023-00081
• Device Sequence Number: 17934194
• Product Code: HTW
• UDI-Device Identifier: 09120047301128
• UDI-Public: 09120047301128
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/30/2023

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: 26/F64286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown