MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE MTP PLATE, CONTOURED, LONG; PLATE, FIXATION, BONE

Catalog Number	AR-8944CL-L
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further facility or 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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.A most likely cause of this type of event is patient non-compliance with the post-operative protocol and begins weight bearing too early.Per product directions for use ((b)(4)), post-operatively, 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 and 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 device.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.
Event or Problem Description
It was reported in the complaint served on arthrex on (b)(6) 2017, and received (b)(6) 2017, that on (b)(6) 2015 the claimant (patient) was treated for a left hallux valgus deformity of the left 1st metatarsohalangeal joint (mtpj) with joint fusion.Arthrex's internal fixation plate, ar-8944-cl-l (lot unknown) was used and placed across the mtph.The plate was reported to have fractured by (b)(6) 2016.On (b)(6) 2016 the claimant underwent surgery for removal of the plate from his left foot.Facility information and additional details have been requested but not yet provided.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further facility or 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.Lot number was not provided so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the plate was broken-off at the non-threaded hole.The device met all material specifications and dimensional analysis as received.A most likely cause of this type of event is patient non-compliance with the post-operative protocol and begins weight bearing too early.Per product directions for use (dfu-0192), post-operatively, 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 and 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 device.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported in the complaint served on arthrex on 5/11/2017, and received 5/16/2017, that on (b)(6) 2015 the claimant (patient) was treated for a left hallux valgus deformity of the left 1st metatarsohalangeal joint (mtpj) with joint fusion.Arthrex's internal fixation plate, ar-8944-cl-l (lot unknown) was used and placed across the mtph.The plate was reported to have fractured by on (b)(6) 2016.On (b)(6) 2016, the claimant underwent surgery for removal of the plate from his left foot.Facility information and additional details have been requested but not yet provided.

• Brand Name: LOW PROFILE MTP PLATE, CONTOURED, LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6629192
• Report Number: 1220246-2017-00208
• Device Sequence Number: 19158978
• Product Code: HRS
• UDI-Device Identifier: 00888867052888
• UDI-Public: 00888867052888
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K052614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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-8944CL-L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 05/18/2018
• 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