MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 04.503.225.01C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported during an orbital floor reconstruction procedure on (b)(6) 2017, the matrixmidface screw broke.Fragment was retrieved.Another screw was used to complete the procedure.No adverse consequence to patient was reported.This report is for one (1) matrixmidface screw self-drilling 5mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed.Manufacturing location: monument manufacturing date: 11-nov-2016 part #: 04.503.225.01c, lot#: h282517 (non-sterile) - ti matrixmidface screw self-drilling 5 mm.Quantities 120.Inspection sheet for inspect dimensional / final inspection - meet acceptance criteria of inspection sheet.Components: raw material part 21015 lot h072911 received from relius medical, llc.Product certification for ti bar received from dynamet meet specification.Rework and raw material receiving/putaway checklist meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: customer quality conducted an investigation of the returned devices.Investigation site: cq zuchwil selected flow: broken visual investigation: the screw head of a broken ti matrixmidface screw self-drilling 5mm length was received for investigation.The complete length of the threaded shaft broke off and is missing.The remaining head does not show damage or wear.The received condition agrees with the complaint description and therefore the complaint is confirmed.The fracture surface is homogenous and shows the typical view of a forced rupture.Dimensional inspection: because of the missing broken off threaded shaft the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Drawing/specification review: not required per selected investigation flow investigation conclusion: based on the condition of the received product and the available poor information a manufacturing conclusion cannot be presented.The fracture surface is homogenous and shows the typical view of a forced rupture hence the most appropriate root cause was mechanical overload.The device history review shows that the correct raw material was used and the implant met fully to our specifications at the time of manufacturing.There were no issues that would contribute to this complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7436932
• MDR Text Key: 105695730
• Report Number: 8030965-2018-53169
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908543
• UDI-Public: (01)07611819908543
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.225.01C
• Device Lot Number: H282517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1