MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø12X320 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18431232S

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient underwent hansson pin lock surgery on (b)(6) 2017, and then she fell down and subtrochanteric fracture occurred.Therefore, revision surgery was performed using t2 reconstruction nail on (b)(6) 2017.In (b)(6) 2017, the t2 reconstruction nail was broken due to pseudoarticulation.On (b)(6)2017, revision surgery was performed.During the surgery, extraction of the distal nail was attempted using extraction hook small and slide hummer, but the tip hook was broke inside the bone.The distal nail was removed with ball-tipped and smooth-tipped guidewire, and the tip hook was retrieved using suction tube and teflon tube.

Manufacturer Narrative

The reported event that reconstruction nail r1.5, ti, left t2 recon ø12x320 mm x 125° was alleged of issue (implant breakage - nail) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.General aspects: the t2 recon nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation.During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Generally, the risk of a breakage will increase with the increase of load cycles and load level.Nail breakage in general has been experienced but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behavior and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased post-operative activities - a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.One requirement for successful nail treatment is a timely bone healing in order to relive the implants over the progressing time of implantation.Another requirement is that the implant must not be damaged during and after insertion.Surface damages reduce the implant¿s durability significantly.A third requirement is that the implant must not be stressed by too high load application e.G.(but not limited to) exceeding weight bearing or overweight or other stresses.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The patient underwent hansson pin lock surgery on (b)(6) 2017, and then she fell down and subtrochanteric fracture occurred.Therefore, revision surgery was performed using t2 reconstruction nail on (b)(6) 2017.In (b)(6) 2017, the t2 reconstruction nail was broken due to pseudoarticulation.On (b)(6) 2017, revision surgery was performed.During the surgery, extraction of the distal nail was attempted using extraction hook small and slide hummer, but the tip hook was broke inside the bone.The distal nail was removed with ball-tipped and smooth-tipped guidewire, and the tip hook was retrieved using suction tube and teflon tube.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø12X320 MM X 125°
• 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: 7153136
• MDR Text Key: 96004701
• Report Number: 0009610622-2017-00385
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K102992
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 18431232S
• Device Lot Number: KOA65E6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2016
• 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): Required Intervention
• Patient Age: 69 YR