MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QR DRILL BIT 3.2MMX127MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number 255589000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 11/22/2018

Event Type  Injury  

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

It was reported that another operative has been injured by a poorly packaged item received from depuy, warsaw.A very sharp drill bit was packaged in a polyethylene bag with no protection on the sharp end.The drill bit has pierced the bag and the operative had cut himself when picking out the item for an order.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint # (b)(4).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.Additional narrative: reported in error.The issue was captured at a jnj distribution center prior to it being sold and as such should not be classified as a complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QR DRILL BIT 3.2MMX127MM
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8178724
• MDR Text Key: 130790863
• Report Number: 1818910-2018-78633
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295142652
• UDI-Public: 10603295142652
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 255589000
• Device Lot Number: KM872189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other