MAUDE Adverse Event Report: ORTHOFIX SRL TITANIUM ANKLE COMPRESSION NAIL 11/200; TITANIUM ANKLE COMPRESSION NAIL 11/2, HSB, JDS

Model Number 99-T771200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2014

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t771200, lot v1341624 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of 22 nails.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot.Technical eval: a technical eval of the device used was not performed as the device is currently in use by pt.The technical eval of the device involved will be performed as soon as the device becomes available.Medical eval: the info made available on the event was sent to our medical evaluator.Please find below an extract of the medical eval."as far as we can tell, in this pt (age and gender not stated), the locking mechanism of a 99-t771200 titanium acn functioned normally on the back table in the operating room, but would not function with the nail had been inserted.It was left in situ, but the static locking bolt was removed and the surgeon performed compression with an external force.The static locked bolt was then reinserted.The end result of the surgery was as had been desired, and the pt should do very well.However, surgical intervention was necessary to achieve this (removal of a previously inserted locking bolt, compression by applying external force, then re-insertion of the locking bolt).This intervention was necessary to decrease the risk of non union in the arthrodesis.As the acn is still in the pt and likely to remain so, we may not know why the mechanism did not function as required." manufacturer comments: a technical eval of the device used was not performed as the device is currently in use by pt.A complete medical eval of the case was not performed as no info about the medical procedure and x-rays have been made available.Based on the few info provided on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.As soon as further info and/or the device involved will be available for the failure investigation, orthofix (b)(4) will promptly re-open the case and finalize the investigation.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The info provided by the local distributor indicates: hospital name: (b)(6).Date of surgery: (b)(6) 2014.Problem observed during clinical use on pt.Event description: per tm - during the case the nail mechanism would move when on the back table but once inside the pt it would not compress.It locked, but it would not compress.Dr.(b)(6) did not remove the nail, he made own compression.The product is not returning for eval.The complaint report form indicates: the surgery was completed with the device.On (b)(6), orthofix (b)(4) received the following additional info: the surgeon took out the static screw and left the one in the top dynamic slot and used a mallet to compress from distal to proximal when filled in calcaneal screws.On (b)(6) 2014, orthofix (b)(4) received the following additional info on the event: the mechanism that did not function, when on pt, was the nail internal mechanism.(b)(4).

• Brand Name: TITANIUM ANKLE COMPRESSION NAIL 11/200
• Type of Device: TITANIUM ANKLE COMPRESSION NAIL 11/2, HSB, JDS
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo,verona ; IT
• Manufacturer (Section G): OPERATIONS INTL, ORTHOFIX SRL
• Manufacturer Contact: roberto donadello, managing dir, ; via delle nazioni 9; bussolengo,verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 3842641
• MDR Text Key: 21167075
• Report Number: 9680825-2014-00015
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 99-T771200
• Device Catalogue Number: 99-T771200
• Device Lot Number: V1341624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention