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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's phone number was not provided.Udi: (b)(4).The date of manufacture was unknown.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported from (b)(6) that at the conclusion of an unspecified surgical procedure, it was observed that the cutter device broke.According to the reporter, all fragments were removed from the patient and the cutting was completed normally.It as reported that there was a delay in the procedure, however it was negligible due to the event occurring at the end of the procedure.A spare device was not needed since the procedure was completed.There was patient involvement.There were no 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
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.It was documented in the initial medwatch that the date of manufacture was nov 11, 2013.The correct date is nov 12, 2013.Udi: (b)(4).The manufacturer location was documented as unknown in the initial report.The location has been updated to waldenburg.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.If additional information should become available, a supplemental medwatch report will be sent 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.The actual device was returned for evaluation.The device was evaluated and it was determined that the device was broken into two pieces and showed blunt saw teeth.Therefore, the reported condition was confirmed.It was noted that this type of damage is a typical sign of recurrent usage and the overall condition of the saw blade represented a heavily used cutting tool.A device history review was performed and no non-conformances were detected related to the reported condition.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 8363777
• Report Number: 8030965-2019-61311
• Device Sequence Number: 1833426
• Product Code: GFA
• UDI-Device Identifier: 07611819996007
• UDI-Public: 7611819996007
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/11/2019

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: 03.000.392
• Device Lot Number: MA1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/25/2019; 03/28/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 02/28/2019; 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1