MAUDE Adverse Event Report: I.T.S. GMBH CORTICAL SCREW, D=3.5MM, L=42MM

Model Number	32352-42
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a surgical procedure was performed for a fracture of the right pelvis plus a fracture of the posterior column acetabulum, starting with the stoppa or langenbeck approach in which a d=3.5mm cortical screw l=42mm and a d=2.7mm drill bit l=220mm broke intra-operatively.
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.

• Brand Name: CORTICAL SCREW, D=3.5MM, L=42MM
• Common Device Name: CORTICAL SCREW, D=3.5MM, L=42MM
• 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: 15273465
• Report Number: 3004369035-2022-00119
• Device Sequence Number: 2658333
• Product Code: HWC
• UDI-Device Identifier: 09120069816778
• UDI-Public: 9120069816778
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/28/2022

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: 32352-42
• Device Catalogue Number: 32352-42
• Device Lot Number: 679/072124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Unknown
• Patient Weight: 75 KG