MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CANCELLOUS BONE SCREW 6.5X30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number	117230000
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	08/24/2013
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
Revision due to pain and elevated metal ions.
Additional 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 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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up 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. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8217280
• Report Number: 1818910-2019-79883
• Device Sequence Number: 1670692
• Product Code: HWC
• UDI-Device Identifier: 10603295007623
• UDI-Public: 10603295007623
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K970929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 117230000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention