MAUDE Adverse Event Report: SYNTHES MONUMENT 24MM COCR RADIAL HEAD; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.024S

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

During radial head prosthesis the set screw broke off while the surgeon was attaching the radial head to the radial stem.The screwdriver is supposed to have a torque limiter attached while inserting the set screw.The limiting device was not attached.The screw head snapped at the head and was removed from the screwdriver tip, and is now available for evaluation.The surgeon continued with the procedure with only the screw shaft securing the head and stem.The procedure was completed to the satisfaction of the surgeon.The screw shaft remains embedded in the radial head, part number 09.402.024s, joining the radial head and radial stem.The surgeon completed the procedure successfully without delay and without any adverse event to the patient.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A review of the device history records has been requested.The investigation could not be completed and no conclusion could be drawn as no device was returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information provided.Nemcomed (presently avalign technologies ¿ nemcomed) manufactured the 24mm cocr radial head standard height, p/n 04.402.024s, lot number 6955108, (b)(4).There were no mrrs, ncrs, or complaint-related issues during the manufacture of the product that would contribute to this complaint condition.

• Brand Name: 24MM COCR RADIAL HEAD
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3677715
• MDR Text Key: 4258759
• Report Number: 1719045-2014-10053
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 09.402.024S
• Device Lot Number: 6955108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 100