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 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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 an open reduction internal fixation (orif) to treat the mandibular fracture, the surgeon was not able to tighten a screw to the matrixmandible plate.The plate was replaced, and the same screw was tightened to the replaced plate without further issues.The procedure was completed without surgical delay.Patient outcome is reported as stable.No further information is available.Concomitant device reported: unknown screw (part# unknown; lot# unknown; quantity: 1).This report is for 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: part 04.503.710s, lot 7l07897: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: july 13, 2020.Expiry date: july 01, 2030.Non-sterile part 04.503.710, lot 47p8093: release to warehouse date: march 06, 2020.Supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.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: 11216006
• MDR Text Key: 228555636
• Report Number: 8030965-2021-00558
• 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: 01/22/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/19/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA