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

Model Number	37251-12
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/29/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STABILIZATION SCREW, D=2.5MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 6696336
• Report Number: 3004369035-2017-00010
• Device Sequence Number: 1972720
• Product Code: HRS
• UDI-Device Identifier: 09120047305195
• UDI-Public: 09120047305195
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 37251-12
• Device Lot Number: 18/522115
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2016
• Initial Report FDA Received Date: 07/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other