MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Sedation (2368); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Unknown when device malfunctioned or infection occurred.Udi: (b)(4).This report is for unknown radial stem/unknown lot number.Original implant surgery in (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.510k#: unknown.The surgeon was only able to remove the radial head but was unsuccessful in removing the stem.There was an additional two hour delay in the surgery while waiting for a smaller radial head to be delivered from another hospital that was located an hour away.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient initially underwent surgery in (b)(6) 2016 for the placement of a left variable angle proximal ulna plate with nine screws and a 24mm radial head and long stem, unknown size, prosthesis by another surgeon.The patient was brought back to the operating room on (b)(6) 2016 for a possible infection at the site of the plate and screws and because the radial head was determined to be too large ((b)(4) for complaint capture of infection and radial head size issue).The stem size was reported to be ok.As the surgeon was removing the plate, three of the 2.7mm screws broke at the head of each screw.The surgeon did not attempt to remove the shaft of the screws and they remain embedded in the patient.A standard operating room x-ray confirmed that all fragments generated by the broken screw heads were removed.It was reported that the fracture had healed and therefore, the hardware was not replaced.However, due to the possible infection, the surgeon irrigated and cleaned around the site of the screws.A specimen was obtained and results are pending.Regarding the radial head and stem, the surgeon was only able to remove the radial head but was unsuccessful in removing the stem.The surgeon utilized the extraction device and pliers for approximately 15 minutes before determining that he was unable to remove the device.There was an additional two hour delay in the surgery while waiting for a smaller radial head to be delivered from another hospital that was located an hour away.The surgeon had initially planned to replace the radial head prosthesis system with a competitor¿s device and thus, a radial head replacement was not readily available.It was reported that the surgeon felt the surgery was completed successfully and the patient was in stable condition.This complaint is for 2 devices.Concomitant devices: variable angle proximal ulna plate (part #unknown, lot #unknown, quantity 1), unknown screws (part #unknown, lot #unknown, quantity 6).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

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.

Event Description

Updated information: it was reported that a patient initially underwent surgery in (b)(6)2016 for the placement of a left variable angle proximal ulna plate with nine screws and a 24mm radial head and long stem, unknown size, prosthesis by another surgeon.The patient was brought back to the operating room on (b)(6) 2016 for a possible infection at the site of the plate and screws and because the radial head was determined to be too large (see com 247007 for complaint capture of infection and radial head size issue).The stem size was reported to be ok.As the surgeon was removing the plate, three of the 2.7mm screws broke at the head of each screw.The surgeon did not attempt to remove the shaft of the screws and they remain embedded in the patient.A standard operating room x-ray confirmed that all fragments generated by the broken screw heads were removed.It was reported that the fracture had healed and therefore, the hardware was not replaced.However, due to the possible infection, the surgeon irrigated and cleaned around the site of the screws.A specimen was obtained and results are pending.Regarding the radial head and stem, the surgeon was only able to remove the radial head but was unsuccessful in removing the stem.The surgeon utilized the extraction device and pliers for approximately 15 minutes before determining that he was unable to remove the device.There was an additional two hour delay in the surgery while waiting for a smaller radial head to be delivered from another hospital that was located an hour away.The surgeon had initially planned to replace the radial head prosthesis system with a competitor¿s device and thus, a radial head replacement was not readily available.It was reported that the surgeon felt the surgery was completed successfully and the patient was in stable condition.This complaint is for four devices.Note: there was a total of 2 hour and 15 minute delay.

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6225560
• MDR Text Key: 63957784
• Report Number: 2520274-2017-10048
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS, PART & LOT UNK, QTY 6; VARIABLE ANGLE PROXIMAL ULNA PLATE/PART & LOT UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 102