MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LOCATOR DRILL

Catalog Number	LDRILL
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), a vial for a step drill was packaged with a cortical bone drill.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: LOCATOR DRILL
• Common Device Name: LOCATOR DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8324306
• Report Number: 3001617766-2019-00050
• Device Sequence Number: 14024698
• Product Code: DZI
• UDI-Device Identifier: 10841307117179
• UDI-Public: 10841307117179
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: Other
• Device Catalogue Number: LDRILL
• Device Lot Number: 127062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1