MAUDE Adverse Event Report: SYNTHES MONUMENT EXPERT END CAP SOLID EXTENS. 10 F/HN TAN

Catalog Number 04.001.002S

Device Problem Difficult to Insert (1316)

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

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: during the operation of proximal humerus, the surgeon picked a 10mm extension end cap, because the proximal part of the nail was found to be planted deep into the bone head.The surgeon tried to insert the end cap with a driver, but it continued spinning around and couldn't be inserted.The surgeon tried a 5mm extension end cap instead, it was inserted without problem.The operation was completed with 20-minute delay.This is 1 of 1 report for complaint (b)(4).

Manufacturer Narrative

This device used for treatment and not diagnosis.Manufacturing documents were reviewed and no complaint related issues were found.The investigation could not be completed; no conclusion could be drawn, as no product was received.Placeholder.

• Brand Name: EXPERT END CAP SOLID EXTENS. 10 F/HN TAN
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: sherry laing ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3625656
• MDR Text Key: 4130260
• Report Number: 1719045-2014-00102
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/20/2014

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: 07/01/2022
• Device Catalogue Number: 04.001.002S
• Device Lot Number: 8002690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1