MAUDE Adverse Event Report: SYNTHES MONUMENT 24MM TRIAL RADIAL HEAD 2MM HT EXTENSION/15.0MM; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 03.402.224

Device Problem Break (1069)

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

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.A product development investigation was performed for the subject device.The subject device was returned with cosmetic scratches and wear evident across most surfaces.The connecting screw is broken into two pieces and was returned with the trial head.Although the exact cause for the complaint condition could not be determined, it is likely the result of excessive tightening and wear.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.This complaint is confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a radial trial head connecting screw broke during a radial head arthroplasty to repair a radial head fracture and dislocation.The surgeon experienced difficulty with surrounding soft tissue in getting the trial head into the trial stem.As the surgeon pushed down forcibly on the screwdriver, the trial head connecting screw broke.There was a reported 3-5 minute surgical delay.Both pieces of the screw were removed and the trial head slid back onto the trial stem successfully.There were no reported fragments left in the patient.The procedure was then completed without further incident.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Report sent to fda on or aroung the month of december 2015, unknown exact date.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint handling unit received a maude report forwarded from facility for med watch #(b)(4).Only additional and/or corrected information will be contained in this report.

• Brand Name: 24MM TRIAL RADIAL HEAD 2MM HT EXTENSION/15.0MM
• 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: 5200488
• MDR Text Key: 30346555
• Report Number: 1719045-2015-10710
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2015,12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.402.224
• Device Lot Number: 7382380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2015
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR