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	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have reviewed the dhf of the affected lot including the material certificate and hardness test certificate.The affected lot went through the normal manufacturing and testing procedures with no deviations or rework noted.The item met all dimensional and visual criteria at the time of release, and no issues were documented during manufacturing that would have resulted in this complaint.Questions regarding the surgical procedure were answered and no specifics were documented.According to clinical opinion, the most common cause of material failure in drilling procedures over target wires is collision of the wire and drill when the wire is bent or the drill deviates from the original target direction.A strongly increased bone hardness in the sense of a pathological change in the bone structure can be ruled out in the present case by the x-ray images.Thus, the probable cause of the drill breakage is the mechanism of tilting.The small metal parts remaining in the bone do not endanger fracture healing, do not pose a risk of infection, and also do not form an obstacle to any screw removal that may be necessary.They therefore pose no risk to the patient even in the further course.During an internal damage analysis, the drilling situation was re-adjusted.A clear clarification of the cause of the drill fracture was not possible.A possible cause could be bending of the drill during the drilling process.
Event or Problem Description
It was reported that a cannulated spiral drill broke intraoperatively.Device was used to pre-drill for a headless compression screw scaphoid fixation.

• 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; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 16289807
• Report Number: 3004369035-2023-00001
• Device Sequence Number: 6766718
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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: 855/335550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/03/2023
• 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