MAUDE Adverse Event Report: ORTHOFIX SRL SCREW EXTRACTOR FOR TIBIAL NAIL

Model Number 17491

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

The patient is a young man (approx.35-40 year old) with a tibial antegrade nail implanted many years ago - more than 10 years ago.The patient arrived to the hospital (b)(6) to remove the nail for personal reasons (not clinical reasons).In the medical records it was not indicated the item implanted, so the surgeons tried to understand the manufacturing company of the nail before scheduling the removal surgery.They contacted orthofix through our sales agent, who provided us the x-rays asking the confirmation that the nail was an orthofix one.We could confirm that the implanted nail is an old orthofix stainless steel tibial nail; the instrumentation required to remove this nail is the same instrumentation as the one required to remove the new centronail titanium tibial nail, with the exception of item 17491 screw extractor for tibial nail, which differs from the centronail extractor only for the diameter of the male thread that engages the nail.Therefore, for this surgery i supplied the hospital with a centronail extraction kit + one 17491, still active in our catalogue.The surgery was performed by dr.(b)(6).The surgeon started by removing one of the two distal locking screws.After performing an oblique skin incision in the forepart of the knee, he created a lateral access standing aside the patellar tendon.The nail was implanted without the proximal locking and without the appropriate end cap.The initial positioning and / or the lack of proximal locking could have caused the nail head to be slightly oblique/rotated medially.This situation in combination with the surgical lateral access, made the engaging of the extractor (code 17491) very difficult, as the soft tissues created a lot of tension around the extractor, that dr.(b)(6) tried to position and screw in the head of the nail; for 2-3 times the surgeon managed to partially engage the thread of the nail with the extractor, although the extractor was not in a perfect coaxial position.During these first engagements also the second distal locking screw was removed.However when the surgeon tried to pull the extractor out, to slide out the nail from the intramedullary canal, the extractor disengaged roughly.It was then clear that it was necessary to better engage the extractor inside the nail.At first the surgeon expressed some doubts about the compatibility between the extractor code 17491 and the nail and wanted to try the extractor contained in the tray of the centronail extraction kit (code 174220), despite i assured him that the instrument 17491 was the correct one.After verifying the impossibility to use item 174220, the surgeon tried again to engage extractor code 17491; to do this he took a surgical hammer, despite i advised him not to use it, and hammered twice in two different moments.The result was that the thread of the extractor stripped and therefore not usable anymore; and it is likely that also the internal threads of the head of the nail stripped.The surgeon then tried to find other solutions, with other different instrumentation but he found nothing suitable.Finally, the patient was sutured with the nail still in situ, without re-applying the distal locking.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 17491s, lot e43 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of (b)(4) units assembled in the product code 17491, lots v1347928, v1348719 and v1354823.(b)(4) of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint notified from this specific device lot.

• Brand Name: SCREW EXTRACTOR FOR TIBIAL NAIL
• Type of Device: SCREW EXTRACTOR FOR TIBIAL NAIL
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo, verona ; IT
• Manufacturer Contact: roberto donadello, md, vp ; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 4718145
• MDR Text Key: 5745961
• Report Number: 9680825-2015-00008
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K961027
• 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: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17491
• Device Catalogue Number: 17491
• Device Lot Number: E43
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1