MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK TRILOGY BONE SCREW SELF-TAPPING; MRA

Catalog Number 00625006520

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 01/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection determined that the bone screw was returned with the outer (b)(6) lid completely removed from the outer cavity.The "peel" tab of the inner (b)(6) lid was sealed between the outer cavity and (b)(6) lid.When the outer lid was removed the inner (b)(6) lid delaminated.The device was used for treatment.There are no prior complaints against this lot.Further corrective and preventive actions were taken at the manufacturing site, including operator awareness training.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that the inner package lid of the self-tapping trilogy bone screw was stuck with the outer (b)(6) sheet.The surgery was completed with another device.

• Brand Name: TRILOGY BONE SCREW SELF-TAPPING
• Type of Device: MRA
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer (Section G): TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5572263
• MDR Text Key: 42970615
• Report Number: 2648920-2016-00142
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Catalogue Number: 00625006520
• Device Lot Number: 62460735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2014
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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