MAUDE Adverse Event Report: I.T.S. GMBH STABILIZATION SCREW, D=2.5MM

Model Number 37251-12

Device Problem Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 01/29/2015

Event Type  malfunction  

Manufacturer Narrative

The locking head of a d=2.3mm stabilization screw popped off the screw.We inspected the quality inspection forms and the material certificates and the no deviation was detected.After receiving the screw head, we started the evaluation and detected under magnifier, that the head only had riffles in the torque profile till the half of depth.This results from a screwdriver which is only inserted half way in the torque profile.Due to this improper insertion, a selective load occurs and thus a higher surface pressure, which can lead in combination with an eccentric load to a failure.

Event Description

The surgeon was engaging the screw into the plate and entire head popped off the screw.The head of the screw remained on the screwdriver.The rest of the screw was left in the patient, but no adverse effects are apparent.

• Brand Name: STABILIZATION SCREW, D=2.5MM
• Type of Device: STABILIZATION SCREW, D=2.5MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; AU 8301
• MDR Report Key: 6696336
• MDR Text Key: 79364722
• Report Number: 3004369035-2017-00010
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 09120047305195
• UDI-Public: 09120047305195
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37251-12
• Device Lot Number: 18/522115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other