MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMANDIBLE 2X2H DCP PL 1.25MM THICK; PLATE, BONE

Catalog Number 04.503.710S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative 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 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a sagittal split ramus osteotomy for treatment of a lower jaw deformity, the surgeon was unable to tighten a screw to the plate.The surgeon replaced the plate with a new one and tightened the same screw without further issues.The procedure was completed without surgical delay.The patient was reported as stable after the procedure.Concomitant devices reported: screwdriver (part number unknown, lot unknown, quantity 1) lock scr 2 self-tap l6 tan (part number 04.503.606.01s, lot unknown, quantity 1).This report involves one (1) ti matrixmandible 2x2h dcp pl 1.25mm thick.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- product complaint #
=
> pc-(b)(4).Investigation summary
=
> product was not returned.Based on the information available, it has been determined that no corrective and preventative 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
=
> steriel part: part: 04.503.710s lot: 7l07897 manufacturing site: selzach supplier: früh verpackungstechnik ag release to warehouse date: 13.Jul.2020 expiry date: 01.Jul.2030 since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Part number:04.503.710 synthes lot number: 47p8093 supplier lot number: n/a release to warehouse date: 06mar2020 expiration date: n/a supplier: jabil-monument no ncrs were generated during production.Device history batch
=
> null device history review
=
> review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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.

• Brand Name: TI MATRIXMANDIBLE 2X2H DCP PL 1.25MM THICK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11207511
• MDR Text Key: 228170422
• Report Number: 8030965-2021-00481
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819974104
• UDI-Public: (01)07611819974104
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• 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: 12/25/2020

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: 04.503.710S
• Device Lot Number: 7L07897
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/24/2021
• Patient Sequence Number: 1
• Treatment: LOCK SCR Ø2 SELF-TAP L6 TAN; UNK - SCREWDRIVERS