MAUDE Adverse Event Report: ARTHREX INC. VOLAR DISTAL RADIAL PLATE TI NARROW LT 5H; PLATE, FIXATION, BONE

Catalog Number	AR-8916VNL-05
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A most likely cause(s) of this type of event include non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient underwent a shoulder procedure when a volar distal radius plate (ar-8916vnl-05, lot: 10041406) was implanted.At some point post-op, the plate broke in half.The surgeon does not believe that the patient had a fall but has not seen this type of plate break like this before.A revision surgery was performed on (b)(6) 2018 to remove the plate.Follow-up investigation: the fracture wasn't healed so the surgeon implanted implants from another manufacturer for the revision.Both, the original and the revision surgery were performed at the same facility with the same surgeon.The following screws were explanted with the plate, ar-8916vnl-05: ar-8724v-14, lot: 194602 x2.Ar-8724v-16, lot: 189143 x2.Ar-8724v-20, lot: 197058 x2.Ar-8935-14, lot: 10147341 x1.Ar-8935-16, lot: 10083240 x1.Ar-8935l-14, lot: 204526 x3.Ar-8935l-18, lot: 202514 x1.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.Complaint confirmed.Visual evaluation revealed the plate had broken in two.There were scratches and gouge marks all along the surface on the top side and scratches and burnishing on the underside of one piece, which probably occurred during initial placement or removal.One fracture appears to be a clean, brittle break whereas the other side appears to have flexed somewhat and bent before breaking.The device met material specifications.A most likely cause of this type of event includes non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2017 the patient underwent a shoulder procedure when a volar distal radius plate (ar-8916vnl-05, lot: 10041406) was implanted.At some point post-op, the plate broke in half.The surgeon does not believe that the patient had a fall but has not seen this type of plate break like this before.A revision surgery was performed on (b)(6) 2018 to remove the plate.Follow-up investigation: the fracture wasn't healed so the surgeon implanted implants from another manufacturer for the revision.Both, the original and the revision surgery were performed at the same facility with the same surgeon.The following screws were explanted with the plate, ar-8916vnl-05: ar-8724v-14, lot: 194602 x2; ar-8724v-16, lot: 189143 x2; ar-8724v-20, lot: 197058 x2; ar-8935-14, lot: 10147341 x1; ar-8935-16, lot: 10083240 x1; ar-8935l-14, lot: 204526 x3; ar-8935l-18, lot: 202514 x1.

• Brand Name: VOLAR DISTAL RADIAL PLATE TI NARROW LT 5H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7540118
• Report Number: 1220246-2018-00193
• Device Sequence Number: 14073926
• Product Code: HRS
• UDI-Device Identifier: 00888867130876
• UDI-Public: 00888867130876
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AR-8916VNL-05
• Device Lot Number: 1004406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other