MAUDE Adverse Event Report: ARTHREX INC. 2.4 X 18MM VAL NEAR CORTEX SCREW , TITANIUM.; PLATE, FIXATION, BONE

Catalog Number	AR-8916VNC-18
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2017
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.This is one of six submissions from the same event.The others are: cc132880-line 216861-00498; cc132880-line 217127-00499; cc132880-line 217129-00501; cc132880-line 213130-00502 and cc132880-line 217178-00503.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.The most likely cause of this event is failure to follow the post-op rehab protocol.The directions for use states: post-operatively, until healing is complete the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient underwent a left distal radius fracture procedure on (b)(6) 2017 where a volar distal radius plate (ar-8916vsl-03) was implanted along with 5 cortex screws.The patient after initial implantation returned home and reports no further issues until follow up with the surgeon.On (b)(6) 2017, a revision was performed to explant the volar distal radius plate and all 5 cortex screws as during the patient's post-op appointment, the surgeon found that all 5 screws were bent and had backed out of their respective locking holes in the distal radius plate.The surgeon reports that patient had no falls, early range of motion or other event that could have occurred that would've caused this issue, however he believes that the patient could have experienced a fall or some type of event that caused this failure to occur but the patient does not reliably give a history of such.Patient is a female, (b)(6).The following devices were explanted during the revision surgery: ar-8916vnc-14, lot: 151596 / line 216861; ar-8916vnc-16, lot: 95141729 / line 217127; ar-8916vnc-18, lot: 95241731 / line 217128; ar-8935-12, lot: 10150458 / line 217129; ar-8935-14, lot: 10158950 / line 217130 and ar-8916vsl-03, lot: 10136975 / line 217178.
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.This is one of six follow-up submissions from the same event due to device evaluation.The others are: cc132880-line 216861-00498; cc132880-line 217127-00499; cc132880-line 217129-00501; cc132880-line 213130-00502 and cc132880-line 217178-00503.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the returned device was bent.The device met material and dimensional specifications as received.The most likely cause of this event is failure to follow the post-op rehab protocol.The directions for use states: post-operatively, until healing is complete the fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.This is the first complaint of this type for this part/ lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient underwent a left distal radius fracture procedure on (b)(6) 2017 where a volar distal radius plate (ar-8916vsl-03) was implanted along with 5 cortex screws.The patient after initial implantation returned home and reports no further issues until follow up with the surgeon.On (b)(6) 2017, a revision was performed to explant the volar distal radius plate and all 5 cortex screws as during the patient's post-op appointment, the surgeon found that all 5 screws were bent and had backed out of their respective locking holes in the distal radius plate.The surgeon reports that patient had no falls, early range of motion or other event that could have occurred that would've caused this issue, however he believes that the patient could have experienced a fall or some type of event that caused this failure to occur but the patient does not reliably give a history of such.Patient is a female, (b)(6).The following devices were explanted during the revision surgery: ar-8916vnc-14, lot: 151596 / line 216861; ar-8916vnc-16, lot: 95141729 / line 217127; ar-8916vnc-18, lot: 95241731 / line 217128; ar-8935-12, lot: 10150458 / line 217129; ar-8935-14, lot: 10158950 / line 217130 and ar-8916vsl-03, lot: 10136975 / line 217178.

• Brand Name: 2.4 X 18MM VAL NEAR CORTEX SCREW , TITANIUM.
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7147521
• Report Number: 1220246-2017-00500
• Device Sequence Number: 135547
• Product Code: HRS
• UDI-Device Identifier: 00888867130739
• UDI-Public: 00888867130739
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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-8916VNC-18
• Device Lot Number: 95241731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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
• Patient Age: 61 YR