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

Model Number	04.503.226.01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10548105
• Report Number: 8030965-2020-07157
• Device Sequence Number: 3073594
• Product Code: DZL
• UDI-Device Identifier: 10887587019178
• UDI-Public: (01)10887587019178
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR