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

Catalog Number LDRILL

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

Per complaint (b)(4), a vial for a step drill was packaged with a cortical bone drill.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: LOCATOR DRILL
• Type of Device: LOCATOR DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8324306
• MDR Text Key: 135724141
• Report Number: 3001617766-2019-00050
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307117179
• UDI-Public: 10841307117179
• Combination Product (y/n): N
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1