MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE T-PLATE, 3.0MM, 4 HOLE, TITANIUM; PLATE, FIXATION, BONE

Catalog Number	AR-8952TT-04
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/10/2016
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 five submissions for the same patient event.The others are: 1220246-2016-00578 ((b)(4)), 1220246-2016-00579 ((b)(4)), 1220246-2016-00580 ((b)(4)), and 1220246-2016-00581 ((b)(4)).No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Customer reported device discarded.
Event or Problem Description
It was reported that the patient had undergone a previous 2nd tmt fusion on (b)(6) 2015.The surgeon was performing a 2nd tmt fusion revision surgery on (b)(6) 2016 due to non-union during which the following devices were explanted: ar-8952tt-04, lot 6791406 ((b)(4)), ar-8933l-24, lot w38572 ((b)(4)), ar-8933l-16, lot 1437750 ((b)(4)), ar-8933-26, lot 157946 (qty 2) ((b)(4)) and ar-8933-28, lot 139580 ((b)(4)).To complete the revision procedure the surgeon was implanting an ar-8952ms-07, 2.4mm 7 hole low profile straight plate ((b)(4)) along with an ar-8724l-18, 2.4mm x 18mm low profile locking screw ((b)(4)) were being implanted in this revision surgery.A 1.7mm drill was used to create the pilot holes for the screws.The surgeon secured the plate with bb taks.He then inserted a 2.4mm locking screw, and the screw had cut through the plate and did not lock in.The 2.4mm plate was removed and the procedure was completed successfully with a 3.0 mm straight mtp plate and screws.No patient injury reported.

• Brand Name: LOW PROFILE T-PLATE, 3.0MM, 4 HOLE, TITANIUM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6178048
• Report Number: 1220246-2016-00577
• Device Sequence Number: 10969897
• Product Code: HRS
• UDI-Device Identifier: 00888867055063
• UDI-Public: 00888867055063
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2016

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-8952TT-04
• Device Lot Number: 6791406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/15/2016
• 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: 58 YR
• Patient Weight: 79