MAUDE Adverse Event Report: SYNTHES MONUMENT RETAIN-SLEEVE F/PANGEAPOLYAX PREASSMBL

Catalog Number 03.620.023

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the tip of the instrument broke during the insertion of the screw in the body.The broken parts were retrieved and returned.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device is an instrument and is not implanted/explanted.A review of the device history records was performed and no complaint related issues were found.The additional evaluation revealed that the investigation found that the holding pin of the complained device is indeed broken off.Please note that this instrument was sold in 2008.This is also clearly visible as the instrument is worn due to repetitive use over the years.Therefore, we suppose that often use and normal wear and tear has led to the reported problem.No product fault could be detected.Placeholder.

• Brand Name: RETAIN-SLEEVE F/PANGEAPOLYAX PREASSMBL
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: t. mccarron ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3938835
• MDR Text Key: 4572442
• Report Number: 1719045-2013-01619
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.620.023
• Device Lot Number: LM015015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1