MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMANDIBLE 6H PLATE 2.0MM THICK; PLATE, FIXATION, BONE

Catalog Number	04.503.728S
Medical Device Problem Codes	Off-Label Use (1494); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional 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: b3: only the event year is known.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that an open reduction/internal fixation surgery for a sternal fracture was performed on an unknown date.Although it was an off-label use, the product was used in surgery at the discretion of the surgeon.During the surgery, an event that appeared to be a locking failure occurred.The surgeon gave up using the product and changed the procedure to a fixation using a wire, and completed the surgery successfully with no delay.The patient outcome was reported to be stable.This report involves one ti matrixmandible 6h plate 2.0mm thick.This is report 1 of 2 for (b)(4).

• Brand Name: TI MATRIXMANDIBLE 6H PLATE 2.0MM THICK
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18326288
• Report Number: 8030965-2023-15692
• Device Sequence Number: 6970506
• Product Code: HRS
• UDI-Device Identifier: 10887587022765
• UDI-Public: (01)10887587022765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.503.728S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCK SCR ø2.4 SELF-TAP L10 TAN 1U I/CLIP
• Patient Sex: Unknown