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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. 2.4 X 16MM VAL NEAR CORTEX SCREW, TITANIUM. PLATE, FIXATION, BONE

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ARTHREX INC. 2.4 X 16MM VAL NEAR CORTEX SCREW, TITANIUM. PLATE, FIXATION, BONE Back to Search Results
Catalog Number AR-8916VNC-16
Device Problems Bent (1059); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 12/12/2017
Event Type  Injury  
Event 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 (b)(4); ar-8916vnc-16, lot: 95141729 / line (b)(4); ar-8916vnc-18, lot: 95241731 / line (b)(4); ar-8935-12, lot: 10150458 / line (b)(4); ar-8935-14, lot: 10158950 / line (b)(4) and ar-8916vsl-03, lot: 10136975 / line (b)(4).
 
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 for device evaluation. The others are: (b)(4). Device history record review revealed nothing relevant to this event. Complaint confirmed. The returned devices met all material and dimensional specifications as received. One device had a slight bend. 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.
 
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 217128-00500; 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 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.
 
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Brand Name2.4 X 16MM VAL NEAR CORTEX SCREW, TITANIUM.
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key7147510
MDR Text Key282032055
Report Number1220246-2017-00499
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867130722
UDI-Public00888867130722
Combination Product (y/n)N
PMA/PMN Number
K150456
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-8916VNC-16
Device Lot Number95241729
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/27/2017 Patient Sequence Number: 1
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