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

Catalog Number 04.503.208.04S

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Additional brand name: scr ø1.5 self-tap l8 tan 4u i/clip.(b)(4).Device was not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.For assembly and sterilization only: 04.503.208.04s - 9482979.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 screw ((b)(4)- 7954148, 04.503.208.20_us_package) got produced in u.S., we have opened an additional dhr task.Manufacturing location: (b)(4); manufacturing date: 18.May.2015; expiry date: 01.May.2025.Dhr review for part # 04.503.208.20, synthes lot # 7954148; release to warehouse date: 17-mar-2015; supplier: manufactured by: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that 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 synthes europe reports an event in (b)(6) as follows: it is reported patient underwent a cheek bone remodeling procedure on (b)(6) 2017.During the procedure, as surgeon was implanting one of the screws, the screw head was detached from the shaft.Surgeon commented that it seemed the screw broke during retightening.The screw head was retrieved and the shaft of the broken screw remains embedded in patient bone.The remaining three (3) screws were implanted and locked into the plate with no problem.Procedure was completed successfully with no delay and no other medical intervention required.One month post-operative there were no patient adverse consequences reported.Concomitant devices reported: matrix midface oblique plate (part 04.503.353s, lot unknown, quantity 1).This report is for one (1) matrix midface screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product code: jey, d10.A device history record review for the (b)(4) material was completed: manufacturing location: (b)(4).Manufacturing date: march 17, 2015.Components: (b)(4) material part 21015 bp80, lot 7821191.(b)(4) material was received from supplier (b)(4).Certificate of test received from (b)(4) certificate of test for titanium ingot meet specification.Per the inspection sheet, the dimensions met inspection acceptance criteria.No non-conformance reports 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.A product investigation was completed: we have received only 3 fragments of the broken screw head for investigation.The complete length of the threaded shaft was not returned (left in patient¿s body).Because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.The manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.The measurable dimensions are well documented and all within the valid specifications.It is likely that too much mechanical force whilst inserting into the bone (or during retightening, as mentioned) caused the breakage of the screw.Proper handling of the screws is documented in the technique guide.We can confirm the visible damages are not from any manufacturing non conformity.No indication for product related issue was found.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: 6493842
• MDR Text Key: 72882883
• Report Number: 9612488-2017-10168
• 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: 03/27/2017

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: 04.503.208.04S
• Device Lot Number: 9482979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1