MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE DEPTH GAUGE; GAUGE, DEPTH

Catalog Number	03.503.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case, the surgeon complained about some broken instruments, to be replaced.There was no other information provided.There was no surgical delay.The procedure was successfully completed.This report is for one (1) matrixmandible depth gauge.This is report 10 of 10 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # : (b)(4).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: 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 bee n 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.
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.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The depth gauge was difficult to use and would not reach the cortices of the bone.No fragments were generated, no additional medical intervention was required.There was no adverse patient impact.

• Brand Name: MATRIXMANDIBLE DEPTH GAUGE
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18491678
• Report Number: 8030965-2024-00675
• Device Sequence Number: 3533615
• Product Code: HTJ
• UDI-Device Identifier: 10887587011622
• UDI-Public: (01)10887587011622
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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: 03.503.036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0/2.4MM UNIV DRILL GUIDE; 2.0/2.4MM UNIV DRILL GUIDE; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-LG; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-LG; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-LG; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-LG; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-MD; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-MD; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-MD; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-MD; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-SH; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-SH; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-SH; MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-SH; MATRIXMANDIBLE DEPTH GAUGE; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/52; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/52; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/52; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/52; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/96; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/96; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/96; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/96; MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/96
• Patient Sex: Unknown