MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK TRILOGY BONE SCREW; LPH

Catalog Number 00625006515

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It was reported when the packaging was opened it was noticed that there was a problem with the head of the screw.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

This report is being amended to reflect changes.The screw was returned with its outer carton and package insert, but not its inner or outer trays or lids.The carton had damage consistent with opening the box, but not as extensive to suggest significant damage during transit.The screw head appears to have been partially crushed, with the head forced into an oblong shape and longitudinal cracks at the head shank and inside the hex feature.The scanning electron microscopy report identified small witness marks near the head shank cracks.There is a notable lack of damage to the screw's blast finish.The sem report also indicated that the cracks appear ductile and do not suggest the screw was in a brittle state.There were no anomalies or deviations associated with review of the device history review.Zimmer ponce investigated the issue and determined that the damage was unlikely to have occurred at the ponce facilities.A definitive root cause for the issue cannot be determined.

• Brand Name: TRILOGY BONE SCREW
• Type of Device: LPH
• 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: 5197527
• MDR Text Key: 30512738
• Report Number: 2648920-2015-00388
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00625006515
• Device Lot Number: 62963967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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