MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SLF TAPPING ROOF PILE SCRW30MM; BONE SCREWS AND PINS : SCREWS

Model Number 1011-40-030

Device Problems Osseointegration Problem (3003); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 04/11/2018

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

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).

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 SCRW30MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9753104
• MDR Text Key: 180854818
• Report Number: 1818910-2020-05985
• Device Sequence Number: 1
• Product Code: JDJ
• UDI-Device Identifier: 10603295000440
• UDI-Public: 10603295000440
• Combination Product (y/n): N
• PMA/PMN Number: K962007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-40-030
• Device Catalogue Number: 101140030
• Device Lot Number: 675623
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR