MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CRESCENTIC BLADE 27MM RADIUS/50MMX0.6MM; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	03.000.395
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer site name and address were unknown.The lot number was unknown; therefore, the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the blade device broke easily.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any 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.
Additional Manufacturer Narrative
The manufacturing site name and address were documented as unknown in the initial report and have been updated accordingly.Device manufacture date: the device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as 9/22/2014.Therefore, the udi has been updated accordingly.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Lot number: the device lot number was unknown in the initial report.Upon receipt of the device, the lot number was identified as ma1010.The udi has been updated accordingly.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was determined that generally, during normal use; the saw blade device becomes dull overtime but does not break in two.It was determined that the device broke due to excessive force.The assignable root cause was determined to be due to improper handling which is misuse and/or user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: CRESCENTIC BLADE 27MM RADIUS/50MMX0.6MM
• 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: 7261725
• Report Number: 8030965-2018-51006
• Device Sequence Number: 19267947
• Product Code: GFA
• UDI-Device Identifier: 07611819996038
• UDI-Public: (01)07611819996038
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2018

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: 03.000.395
• Device Lot Number: MA1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 03/07/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 02/22/2018; 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1