MAUDE Adverse Event Report: SYNTHES BETTLACH TI MATRIXMIDFACE SCREW SELF-TAPPING 8MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 04.503.208.01S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Additional device product code: jey.(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter address and phone number is not provided for reporting.A device history record (dhr) review was performed for part # 04.503.208.01s, lot # l349996: please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 21.Mar.2017 expiry date: 01.Mar.2027: no non-conformance reports (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.Non-sterile 72577/ h139052 was manufactured in us: a dhr review was performed for non-sterile part #: 04.503.208.20, lot#: h139052 (non-sterile) - ti matrixmidface screw self- tapping 8 mm.Qty: 60: manufacturing location: (b)(4), manufacturing date: 07-jul-2016: components parts reviewed: raw material part 21015 bp80 lot 9954180.Raw material was received from supplier (b)(4).Certificate of test received from (b)(6) for titanium ingot meet specification.Raw material rework inspection created 19-feb-2016 for inspection for lims gage.Raw material receiving/putaway checklist meet specification.Inspection sheet- inspect dimensional final inspection met inspection acceptance criteria.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that the screw was broken below the screw-head when inserting the screw via pilot hole at the patient¿s maxillary bone for fixing matrix midface plate during maxillary osteoplasty surgery on (b)(6) 2017.The surgeon tried to explant the remained screw shaft, however, it was difficult to explant because of a narrow view.So, the surgeon decided to keep the remained screw shaft in the patient¿s maxillary bone.The surgery was completed by creating another pilot hole and using alternative screw to fix the plate.There was no surgical delay.Patient outcome reported as okay.Concomitant devices reported: matrix midface plate (quantity 1), screw (quantity 1).This report is for one (1) ti matrixmidface screw self-tapping 8 mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A product investigation was performed.The investigation has shown that one va locking screw is broken just below the screw head; screw shaft was not returned as it is still implanted in patient¿s bone.There are some organic residues visible on the remaining screw portion.The review of the production histories revealed that this matrix midface screw was manufactured in march 2017 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.In addition, the raw material certificate indicates that the used material met the specifications as well.The dimensions of the returned, broken screw could not be verified due to the damage incurred.No manufacturing related issues that would have contributed to this complaint were found; the failure mode is consistent with a mechanical overloading.No product related issues identified.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-TAPPING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6901489
• MDR Text Key: 89473885
• Report Number: 9612488-2017-10496
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083388
• 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,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.208.01S
• Device Lot Number: L349996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1