MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM TI CORTEX SCR SLF-TPNG WITH PLUSDRIVE(TM) RECESS 6MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 400.036

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: jey.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent reduction of facial mass fracture on (b)(6) 2019.A drill bit broke during drilling in the patient's bone prior to insertion of the cortex screw.The cortex screw was introduced into the patient, but when reviewing the depth, the doctor saw the need to change the implant for a longer one to obtain the desired result.The broken piece was recovered as it was not inserted in the patient.Procedure was successfully completed with no surgical delay.The patient has not presented anything, the surgery was performed without problems.This report is for one (1) 1.5mm ti cortex screw self-tapping with plusdrive(tm) recess 6mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 1.5MM TI CORTEX SCR SLF-TPNG WITH PLUSDRIVE(TM) RECESS 6MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8329150
• MDR Text Key: 136029063
• Report Number: 8030965-2019-60889
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819784505
• UDI-Public: (01)07611819784505
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K102656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR