MAUDE Adverse Event Report: SYNTHES GMBH MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH; BONE PLATE

Catalog Number 04.503.825.05

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/09/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on feb 9, 2021 during a maxillary and mandibular jaw fracture procedure, the surgeon was unable to attach the matrixwave mmf screw to the unknown cmf insertion instrument.The procedure was successfully completed.There was no patient consequence.There is no further information available.This report is for one (1) matrixwave mmf ti 1.85mm screw self-drilling/8mm length.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.

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.H3, h4, h6: part 04.503.825.05, lot 27p2652: manufacturing location: monument.Manufacturing date: november 26, 2019.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture 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.

• Brand Name: MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11439233
• MDR Text Key: 280450024
• Report Number: 8030965-2021-01717
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07612334093479
• UDI-Public: (01)07612334093479
• Combination Product (y/n): N
• PMA/PMN Number: K141165
• 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: 02/10/2021

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: 04.503.825.05
• Device Lot Number: 27P2652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/05/2021
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: CMF