MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW45MM; BONE SCREWS AND PINS : SCREWS

Model Number	1011-40-045
Medical Device Problem Codes	Osseointegration Problem (3003); Unintended Movement (3026)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	04/11/2018
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
Ppf and sticker sheets received.There were no allegations reported however the patient was revised and the reason for revision was not provided.Doi: (b)(6) 2017.Dor: (b)(6) 2018, (left hip, fifth revision).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SLF TAPPING ROOF PILE SCRW45MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9753111
• Report Number: 1818910-2020-05988
• Device Sequence Number: 2366341
• Product Code: JDI
• UDI-Device Identifier: 10603295000471
• UDI-Public: 10603295000471
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 1011-40-045
• Device Catalogue Number: 101140045
• Device Lot Number: 628546
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2020
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR