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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Exact date of post-operative non-union is unknown.This report is for one (1) unknown synthes radial head device.The original implant procedure was performed on an unknown date.The complainant part is not expected to be returned for manufacturer review/ investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a valid lot number, a review of the device history records could not be requested.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

It was reported that a patient underwent a radial head replacement procedure on (b)(6) 2016 due to an identified non-union.The patient's original fracture was treated on an unknown date with the implantation of synthes hardware.Following the identification of the non-union, the surgeon deemed that the issue could not be repaired, so a removal procedure was conducted.Despite the intra-operative breakage of one of the utilized instruments, the procedure was completed successfully utilizing routine x-ray imaging throughout.A fifteen (15) second delay was noted as a result of the intra-operative issue.Post-operatively, the patient's status was said to be "as expected." this report will address the post-operative non-union, which was the reason for revision.The intra-operative issues encountered will be captured in and reported under related complaint (b)(4).This report is for one (1) unknown synthes radial head device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Adverse event and/or problem, outcomes attributed to adverse events, describe event or problem, type of reportable event: the initial complaint was reviewed and found not reportable.I conclude the information in this complaint record does not suggest that a device malfunction occurred.The reported event is not a result of a device malfunction.There is no indication that this device caused or contributed to the reported event.There is no indication of additional medical/surgical interventions related to our device.Additional information was received stating that the nonunion occurred prior to implantation of our device.The original doctor wanted to treat the patient conservatively without any device.Afterwards the patient did not heal and there was a nonunion then during the second visit to the doctor that is when our device was implanted.Therefore, this will be non-reportable.Should further information become available this determination will be reviewed accordingly.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

The initial complaint was reviewed and found not reportable.I conclude the information in this complaint record does not suggest that a device malfunction occurred.The reported event is not a result of a device malfunction.There is no indication that this device caused or contributed to the reported event.There is no indication of additional medical/surgical interventions related to our device.Additional information was received stating that the nonunion occurred prior to implantation of our device.The original doctor wanted to treat the patient conservatively without any device.Afterwards the patient did not heal and there was a nonunion then during the second visit to the doctor that is when our device was implanted.Therefore, this will be non-reportable.Should further information become available this determination will be reviewed accordingly.

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6010585
• MDR Text Key: 56789343
• Report Number: 2520274-2016-14821
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• 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
• Patient Outcome(s): Required Intervention