MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø11X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18261136S

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

It is reported by the surgeon of the hospital, that he was performing a surgery procedure.During this procedure it wasn't possible to remove the t2 scn nail because it wasn't possible to catch the nail.A foreign removal set was used for the removal of the nail but this failed as well.During a surgery time of approximately 4 hours it wasn't possible to remove the nail.The nail still remains in the patient and has to be removed with another surgery.

Manufacturer Narrative

Evaluation revealed the t2 supracondylar nail as primary product.The review of manufacturing documents revealed no deficiency in material and no deficiency in manufacturing.Dimensional examination could not be carried out but an undamaged nail after an implantation period of approx.18 months did not suspect any deficiency.A review of the risk management file revealed that potential unsuitable drill hole configuration had been considered.Evaluation results did not indicate a non-conformity, adverse trend or unanticipated hazard.No further action is required at this time.General aspects: the nail in question is a temporary implant which is intended to hold the reposition, to bridge load application for a limited time and to assist in bone healing.In this case above purposes were completely fulfilled by the implant within 1, 5 years.As mechanical properties of the material as well as dimensions were within specified tolerances we exclude faults in material or manufacturing.The nail in question has in total 6 drill holes for fixation.According to received information only 2 drill holes had been occupied by corresponding locking screws.Referring to a completely healed bone it could be possible that bone had (partly) grown into the remaining open drill holes preventing easy removal after 1, 5 years.At the time of reporting bone growth had continued for another 6 weeks.The medical assessment came to the conclusion that the nail itself had become ¿built-in¿ ¿ at least in the proximal area ¿ which most likely contributed to that the nail could not be removed.It was pointed out that such situation is known but not unlikely in young patients.According to above the reported event has to be classified as not device related.The file will be closed formally.In case relevant information resp.The part(s) become available we reserve the right to update the investigation and to change the root cause.With available information a deficiency of the nail was not verified.

Event Description

It is reported by the surgeon of the hospital, that he was performing a surgery procedure.During this procedure it wasn't possible to remove the t2 scn nail because it wasn't possible to catch the nail.A foreign removal set was used for the removal of the nail but this failed as well.During a surgery time of app.4 hours it wasn't possible to remove the nail.The nail still remains in the patient and has to be removed with another surgery.

• Brand Name: SUPRACONDYLAR NAIL T2 SCN Ø11X360MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5532829
• MDR Text Key: 41655554
• Report Number: 0009610622-2016-00168
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K023267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 18261136S
• Device Lot Number: K07D6CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR