MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANCELLOUS BONE SCREW 6.5X30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	117230000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
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
Cancellous bone screw 6.5 30 mm, code (b)(4), lot hm1711 q-ty 1 pc.During procedure half of cap of screw was broken.No patient harm.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: CANCELLOUS BONE SCREW 6.5X30MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7820201
• Report Number: 1818910-2018-67824
• Device Sequence Number: 11110656
• Product Code: HWC
• UDI-Device Identifier: 10603295007623
• UDI-Public: 10603295007623
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K970929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: Health Professional
• Device Catalogue Number: 117230000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1