MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS SCREW, CANNULATED, D=4.0MM

Model Number 3140*

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

We have inspected the qc documents of the last three batches of the affected device shipped to the distributor 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.The initial reporter stated that the 4.0mm were used for a subtalar arthrodesis fixation, which is not indicated in the ifu.If further details become available, we proceed with a mdr follow-up report.

Event Description

It was reported that a 4.0mm cannulated cancellous screw broke post-operatively after an unknown time.Screw was used for indication not stated in the ifu - off-label use.Original implant date unknown.

• Brand Name: CANCELLOUS SCREW, CANNULATED, D=4.0MM
• Type of Device: CANCELLOUS SCREW, CANNULATED, D=4.0MM
• 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: 9652256
• MDR Text Key: 190537134
• Report Number: 3004369035-2020-00002
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K060156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3140*
• Device Catalogue Number: 3140*
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention