MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIX MIDFACE SCREW . SELF-DRILLING 6MM; SCREW FIXATION INTRAOSSEOUS

Model Number 04.503.226.01

Device Problem Break (1069)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 history lot: part #: 04.503.226.01c, synthes lot number: 13l2748, supplier lot #: 13l2748, release to warehouse date: jul 19, 2019, supplier: (b)(4).Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 (b)(6) reports an event as follows: it was reported on an unknown date that the patient underwent for cranioplasty to fix the matrix neuro system with plates and screws to the psi peek designed for the patient.During the surgery, when tightening the self-drilling screw breaks and unable to extracted from the device.Also, the drill bit was stopping the system and the screw has broken during the final tightening time.The surgery was completed successfully with 60 minutes delay.Some generated fragments are remains in the patient.There were no consequences of the patient.Concomitant devices reported: unknown plates: matrixneuro (part # unknown, lot # unknown, quantity # 1), unknown drill bit (part # unknown, lot # unknown, quantity # 1).This complaint involves two (2) devices.This report is for (1).Ti matrix midface screw self-drilling 6mm.This is report 1 of 2 (b)(4).

• Brand Name: TI MATRIX MIDFACE SCREW . SELF-DRILLING 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: 10548105
• MDR Text Key: 207508528
• Report Number: 8030965-2020-07157
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.503.226.01
• Device Catalogue Number: 04.503.226.01C
• Device Lot Number: 13L2748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR