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

Catalog Number	255589000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/22/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that another operative has been injured by a poorly packaged item received from depuy (b)(4).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.
Additional 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.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
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8185271
• Report Number: 1818910-2018-78875
• Device Sequence Number: 1987747
• Product Code: HTW
• UDI-Device Identifier: 10603295142652
• UDI-Public: 10603295142652
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 255589000
• Device Lot Number: KM872189
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 04/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention