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

Catalog Number 09.402.026S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device broke intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that: manufacturing location: supplier (b)(4), packaged by: (b)(4).Manufacturing date: 15-jan-2013.Expiration date: 30-nov-2017.Part #: 09.402.026s lot#: 6905537 (sterile) - 26mm cocr radial head standard height/13.5mm - sterile.Qty.(b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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 head prosthesis disengaged from the connecting screw and the radial stem after implantation during a procedure to repair radial head fracture on (b)(6) 2016.After a 26mm radial head had been locked down into the radial stem, final c-arm xrays were taken.Subsequently, a click was felt by the surgeon during limb range of motion testing.Additional lateral x-rays confirmed that the radial head had disengaged from the stem.When the surgeon removed the head, he discovered that the connecting screw had engaged into the stem, and the radial head had disengaged from the connecting screw.The 26mm head was replaced with a 24mm radial head for the final construct.There was a reported 20-30 minute surgical delay and additional x-rays were required.The procedure was completed successfully with the patient in stable condition.This complaint involves one device concomitant device reported: radial stem (part #04.402.010s, lot # 6970377, quantity 1), 1.2 nm torque limiting attachment (part # unknown, lot #unknown, quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).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

Device was used for treatment, not diagnosis.One (1) 26 mm cocr radial head standard height / 13.5 mm - sterile (part number 09.402.026s, lot number 6905537) was received.A visual inspection, functional test, and drawing review were performed as part of this investigation.The complaint condition is confirmed as the radial head was received with the connecting screw component and head component disassembled.The slot of the head component shows indents consistent with the connecting screw being forced through the slot.Wear was also observed on the mating diameter of the connecting screw and the drive recess.However, when assembled with a radial stem the axial forces would be transferred through the mating flats of the head and stem and not allow the screw to be pulled out.Functional testing showed that under significant force the screw could be pressed back into the slot where it was retained as intended.The balance of the device has various scratches and marks consistent with use.Thus, the complaint condition is confirmed and consistent with the reported condition.The condition could not be replicated as, when reassembled, the screw was properly retained.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.(all dimensional inspections completed with calipers).The returned radial head contains an integrated connection screw which is intended to attach to a radial stem to form the two-piece construct.This construct is intended for primary and revision joint replacement of the radial head.This information is provided per the radial head prosthesis system technique guide.A review of the current design drawing / manufactured revision was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Thus, a definitive root cause could not be determined as the circumstance that resulted in the force required to pull the connecting screw out of the radial head component is unknown.One (1) torque limiting attachment (part number 03.110.002, lot number 3315) was returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.Corrected data: the radial head disengaged from the connecting screw and radial stem intraoperatively, therefore, was not implanted/explanted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 26MM COCR RADIAL HEAD STANDARD HEIGHT/13.5MM-STERILE
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6041393
• MDR Text Key: 57869165
• Report Number: 1719045-2016-10764
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• 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: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 09.402.026S
• Device Lot Number: 6905537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: .2 NM TORQUE LIMITING ATTACHMENT PART & LOT# UNK; RADIAL STEM PART #04.402.010S, LOT # 6970377 QTY1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 36