MAUDE Adverse Event Report: SYNTHES GMBH CRESCENTIC BLADE 12MM RADIUS/45MMX0.6MM; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	03.000.390
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a tibial-plateau-leveling osteotomy surgical procedure for anterior cruciate ligament rupture, it was discovered that the crescentic blade 12mm radius/45mmx0.6mm device had poor sharpness.It was reported that there was a thirty-minute delay to the surgical procedure.There was no human patient involvement as the device was used in a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H11 additional narrative: h6: device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CRESCENTIC BLADE 12MM RADIUS/45MMX0.6MM
• Common Device Name: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 21933097
• Report Number: 8030965-2025-04284
• Device Sequence Number: 13017350
• Product Code: GFA
• UDI-Device Identifier: 07611819995987
• UDI-Public: (01)07611819995987(10)MA2014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2025

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: 03.000.390
• Device Lot Number: MA2014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 06/02/2026
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 09/04/2025; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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
• Patient Sex: Unknown