MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM; BONE SCREWS AND PINS : SCREWS

Model Number 1217-25-500

Device Problem Material Twisted/Bent (2981)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); Hypoesthesia (2352); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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.

Event Description

Patient was revised to address painful hip.Doi: unknown; dor: (b)(6) 2017; right hip.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9622244
• MDR Text Key: 176234352
• Report Number: 1818910-2020-02641
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009900
• UDI-Public: 10603295009900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 1217-25-500
• Device Catalogue Number: 121725500
• Device Lot Number: C75GP4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 97