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 Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).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 corner of the cutter device broke off.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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.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.
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.D4, d1, d2: the catalog number was reported as 03.000.396 in the initial report, which has been updated to 03.000.394.The brand name, common device name and procode have been updated accordingly.If additional information should become available, a supplemental medwatch report will be sent 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: 9215470
• Report Number: 8030965-2019-69509
• Device Sequence Number: 3730793
• Product Code: GFA
• UDI-Device Identifier: 07611819996045
• UDI-Public: 07611819996045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2019

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
• Device Lot Number: MA2001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/23/2019; 11/08/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1