MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CRESCENTIC BLADE 24MM RADIUS/45MMX0.6MM; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	03.000.394
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device serial or lot number was unknown.The device manufacturer site name and address were unknown.The device manufacture date was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that the cutter device had a crack and two broken teeth.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use.There was no human patient involvement as this was a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: CRESCENTIC BLADE 24MM RADIUS/45MMX0.6MM
• Common Device Name: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7523804
• Report Number: 8030965-2018-53826
• Device Sequence Number: 1696575
• Product Code: GFA
• UDI-Device Identifier: 10886982065988
• UDI-Public: (01)10886982065988
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: 03.000.394
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1