MAUDE Adverse Event Report: I.T.S. GMBH SPIRAL DRILL, D=3.5MM, L=305MM, AO CONNECTOR

Model Number	61253-305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the qc documents of the lot 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.As soon further essential information get available a follow-up medwatch form will be filed.This is report 1/2.
Event or Problem Description
Patient scheduled to complete a surgical procedure for fracture of the anterior pelvis and posterior acetabulum.During the development of the surgery, the doctor requires drills with a diameter of 2.5 mm, short and long, to perform the brocade procedure, measurement, and later implantation of the cortical screws with a diameter of 3.5mm and plate fixation.After having implanted the second screw and when the doctor was preparing to drill for the implantation of the third screw, the spiral drill with a diameter of 2.5 mm, length 220 mm (reference: (b)(4)) splits, leaving the tip at bone level within the patient.The doctor tries to extract the fragment of the drill bit that is in the patient, but it is not possible because he had a comminuted fracture and in addition to this he has to reposition the location of the screw to be implanted.The doctor continued with the surgery, so he required the spiral drill, diameter 2.5 mm, length 305 mm (reference: (b)(4)) to be able to continue, but when he was drilling for the implantation of the last screw of 12 implanted, this other drill bit also breaks and like the previous one, the tip remains at the bone level inside the patient.

• Brand Name: SPIRAL DRILL, D=3.5MM, L=305MM, AO CONNECTOR
• Common Device Name: SPIRAL DRILL, D=3.5MM, L=305MM, AO CONNECTOR
• 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, 8301 ; AU 8301
• MDR Report Key: 15121470
• Report Number: 3004369035-2022-00121
• Device Sequence Number: 5646424
• Product Code: HTW
• UDI-Device Identifier: 09120069818093
• UDI-Public: 9120069818093
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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): 07/20/2022

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: 61253-305
• Device Catalogue Number: 61253-305
• Device Lot Number: 23/201781
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG