MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX15MM; HIP OTHER IMPLANT

Catalog Number 121715500

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Event Description

During primary total hip replacement surgery, the screw driver became stuck on the screw.After five minutes trying to remove the screwdriver from the screw, it pulled the screw completely out of the drill hole and the wound.After inspection, it was noted that the screw head did not show any damage and the screwdriver was not stripped.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The devices associated with this report were not returned.Previous investigations found this failure mode for the instrument code was reviewed under (b)(4).Preliminary risk assessment (b)(4) was conducted in april 2015 and determined this failure was related to user dissatisfaction and resulted in broadly acceptable risks.Based on the investigation, no corrective action indicated.Complaints will be monitored through post market surveillance sep 419.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5001098
• MDR Text Key: 23400463
• Report Number: 1818910-2015-28010
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121715500
• Device Lot Number: D14092616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR