MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CRESCENTIC BLADE (18.0 X 0.51 X 30.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	5400031417
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
Investigation results indicate that the reported failure of sterility breach (sticking through the packaging) was not confirmed.Markings were observed on the internal cavity surface of the blister where the teeth of the blade were in contact with it.It was visually clear that these markings were not a hole through the blister and only marking on the internal surface of the blister which could have been caused during handling and distribution.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.

• Brand Name: CRESCENTIC BLADE (18.0 X 0.51 X 30.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8044066
• Report Number: 0001811755-2018-02373
• Device Sequence Number: 11078232
• Product Code: GFA
• UDI-Device Identifier: 04546540467256
• UDI-Public: 04546540467256
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 Expiration Date: 09/01/2020
• Device Catalogue Number: 5400031417
• Device Lot Number: 15267017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1