MAUDE Adverse Event Report: ARTHREX INC. VOLAR DISTAL RADIAL PLATE TI STD LT 3H; PLATE, FIXATION, BONE

Catalog Number AR-8916VSL-03

Device Problems Bent (1059); Migration or Expulsion of Device (1395)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/12/2017

Event Type  Injury  

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: (b)(4).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 / (b)(4); ar-8916vnc-16, lot: 95141729 / (b)(4); ar-8916vnc-18, lot: 95241731 / (b)(4); ar-8935-12, lot: 10150458 / (b)(4); ar-8935-14, lot: 10158950 / (b)(4) and ar-8916vsl-03, lot: 10136975 / (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 due to device evaluation from the same event.The others are: cc132880- (b)(4); cc132880- (b)(4); cc132880- (b)(4); cc132880- (b)(4) and cc132880 - (b)(4).Device history record review revealed nothing relevant to this event.Complaint not confirmed.The returned device met all material and dimensional specifications as received.No problem found with device upon our evaluation.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 / (b)(4); ar-8916vnc-16, lot: 95141729 / (b)(4); ar-8916vnc-18, lot: 95241731 / (b)(4); ar-8935-12, lot: 10150458 / (b)(4); ar-8935-14, lot: 10158950 / (b)(4) and ar-8916vsl-03, lot: 10136975 / (b)(4).

• Brand Name: VOLAR DISTAL RADIAL PLATE TI STD LT 3H
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7147525
• MDR Text Key: 95811592
• Report Number: 1220246-2017-00503
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (y/n): N
• PMA/PMN Number: K131474
• Number of Events Reported: 1
• 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 Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-8916VSL-03
• Device Lot Number: 10136975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR