MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CRESCENTIC BLADE 18MM RADIUS/45MMX0.6MM; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	03.000.392
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.The serial number was unknown.The reporter's facility name and address were not available.The manufacturing location was unknown.The device manufacture date was unknown.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during an orthopedic tibial plateau leveling osteotomy veterinary procedure, it was observed that there was breakage on the blade device.It was reported that there was an unspecified amount of delay to the surgical procedure.It was further reported that a spare blade device was available for use and the procedure was completed successfully.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 will be submitted accordingly.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the saw blade had broken into two pieces and the device had residue and signs of wear.It was noted that the saw blade showed signs of stress with side forces while being used which is user error.Therefore, the reported condition was confirmed.The assignable root cause was traced to user error.A device history review was performed, and no non-conformances were detected related to the reported condition.D4: the lot number of the device was documented as unknown in the initial medwatch report.This has been updated to ma1007.The unique identifier (udi) has been updated accordingly.G1-2: the manufacturer location was unknown in the initial report.The location has been updated to waldenburg.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.H4: the device manufacture date was reported as unknown in the initial medwatch report.This has been updated to oct 16, 2012.Udi: (b)(4).

• Brand Name: CRESCENTIC BLADE 18MM 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: 10148748
• Report Number: 8030965-2020-04116
• Device Sequence Number: 2101861
• Product Code: GFA
• UDI-Device Identifier: 07611819996007
• UDI-Public: 07611819996007
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 03.000.392
• Device Lot Number: MA1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1