MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX15MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121715500

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Total hip joint replacement; (b)(6), (b)(6) hospital (b)(6) 2018.Screw was reportedly opened and the inner plastic casing was stuck to the outside packaging, therefore ripping the outer and making the screw unsterile.Another screw was opened instead and the unsterile screw passed off.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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).Updated march 05, 2019.The packaged device was returned for examination.Examination of the returned packaging materials confirms a tear drop shaped hole in the inner packaging.In addition the inner pouch was returned opened in entirety.A root cause cannot be conclusively determined.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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 : null.Device history batch : null.Device history review : null.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: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7407792
• MDR Text Key: 104823410
• Report Number: 1818910-2018-56923
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009306
• UDI-Public: 10603295009306
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• 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: PU122187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1