MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRILL BIT D2.5 X 170 MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number 230790005

Device Problems Break (1069); Entrapment of Device (1212); Optical Decentration (1360)

Patient Problem Not Applicable (3189)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

While pre drilling the glenoid with the 2.5mm drill bit ahead of glenoid screw placement in a delta xtend procedure the tip of the drill bit has snapped and remained lodged in the glenoid vault.The snapped drill bit was picked up by the scrub nurse while packing the drill bit away.The surgeon was informed and the spare drill bit was used to measure up against the broken part to determine the amount of metal that had snapped off.No obvious technique failure was observed during the pre drilling process and the surgeon was unaware of the break until the scrub nurse informed him.The finding was only made following insertion of four screws (30mm superior & inferior, 18mm posterior & anterior) and the glenosphere and thus completion of the glenoid component.Ii was called in and images revealed tip of drill bit was lodged in anterior drill hole ahead of 18mm screw.No action was taken to remove screw as surgeon was confident drill tip was not impacting vital structures and lodged in bone.

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.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL BIT D2.5 X 170 MM
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9281932
• MDR Text Key: 165986812
• Report Number: 1818910-2019-114283
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295116547
• UDI-Public: 10603295116547
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230790005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1