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

Catalog Number 00625006535

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported that during surgery the head of the screw broke off.The remainder of the screw was unable to be removed.

Manufacturer Narrative

The screw shaft remains in vivo and no product was returned for review.Review of the device history records indicates that the device was manufactured to specification and did not identify any deviations or anomalies.There have been no other complaints for this part/lot combination, to date.Without analysis of the fractured screw head, and with the present information, this fracture is considered a one-off event for this manufacturing lot, and a specific cause cannot be determined with certainty at this time.

• Brand Name: ZIMMER SELF-TAPPING BONE SCREW
• 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: 5021620
• MDR Text Key: 24679528
• Report Number: 2648920-2015-00311
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/27/2015

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: No Information
• Device Catalogue Number: 00625006535
• Device Lot Number: 62818720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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 Age: 45 YR
• Patient Weight: 55