MAUDE Adverse Event Report: SYNTHES MONUMENT 26MM TRIAL RADIAL HEAD STANDARD HEIGHT/13.5MM; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 03.402.026

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.It was reported the screw that fell out was lost or discarded and will not be returned with the rest of the device.Part number: 03.402.026, synthes lot number: 7406216: release to warehouse date: october 01, 2013.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported that a set screw fell out of a 26mm standard height trial radial head prosthesis during a radial head prosthesis placement surgery on (b)(6) 2016.The set screw was retrieved and placed on the back table.The surgery was successfully completed using a different size head.There was no surgical delay.The patient outcome was reported as fine.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: one 26mm trial radial head, standard height, 13.5mm (part number 03.402.026, lot number 7406216) was received with the complaint category of ¿does not/will not function: fell apart.¿ it was reported that a set screw fell out of 26mm standard height trial radial head prosthesis during a radial head prosthesis placement surgery.A device history record (dhr) review, visual inspection, functional test, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The trial implant was received without the screw component.Since the screw was not received, the complaint condition of ¿fell apart¿ is confirmed and consistent with the reported condition.However, the issue could not be replicated when functionally tested with gage pins.The customer quality engineering investigation shows that this device is used during radial head replacement surgeries to determine the appropriately size implant.The trial implant was received without the screw component.Worn edges were observed on the screw slot.The balance of the device has various scratches and marks consistent with use and sterilization.The returned part was determined to be suitable for the intended use when employed and maintained as recommended and the risk assessment was found to adequately address the complaint condition.The root cause could not be definitively determined as the head component functions as intended and the screw component was not received for evaluation.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device 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.

• Brand Name: 26MM TRIAL RADIAL HEAD STANDARD HEIGHT/13.5MM
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5697300
• MDR Text Key: 46494103
• Report Number: 1719045-2016-10454
• 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,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.402.026
• Device Lot Number: 7406216
• Other Device ID Number: (01)10886982079954(10)7406216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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: 51 YR