MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOTACK FLEX DRILL BIT; BIT, DRILL

Catalog Number	00CAT01859
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that an expired device was used.
Event or Problem Description
It was reported that an expired device was used.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: expired probable root cause: - design - validated shelf life too short - application -distribution inefficient, sat too long in inventory before being shipped to customer.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: NANOTACK FLEX DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8215493
• Report Number: 0002936485-2019-00005
• Device Sequence Number: 1631228
• Product Code: HTW
• UDI-Device Identifier: 07613252633112
• UDI-Public: 07613252633112
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 00CAT01859
• Device Lot Number: 17082AG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1