MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965042S

Device Problem Break (1069)

Patient Problems Sepsis (2067); Non-union Bone Fracture (2369)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) university hospital (b)(6).The title of this report is ¿analysis of the t2 recon nail used with the antegrade locking mode¿ which was released in june 2018 and is associated with the t2 recon nailing system.Within that report, postoperative complications/ adverse events were reported, which occurred between january 2014 and november 2017.Based on the available device and patient information and a review of complaint handling database it was revealed that the events have not been reported by the hospital or by the author of the report, therefore 15 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses septic nonunion discovered from the event of case (b)(4).One out of 1 case.The pmcfr states: ¿in the second case (case (b)(4)) it was a transverse fracture (32-a) in a heavy (b)(6) lady.She is (b)(6).The breakage of all three locking screws was observed.In fact a septic nonunion was observed and a revision surgery was performed 142 days after the initial surgery.All the broken screws were removed (18965050s-k05d869;18965050s-k0af9e2;18965042s-k074ffc), the nail was also removed (18471136s-k0dadeb) the medullary canal was reamed and a t2 a/r nail was then used.Antibiotics were used during 4 months.¿.

Manufacturer Narrative

Corrections to executive summary: (this product inquiry addresses implant breakage.2 (b)(4) out of 3 cases.) the reported event that locking screw, fully threaded t2 tibia ø5x42,5 mm was alleged of issue k-556 (revision) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.As per event description¿ the lady has a bmi of 36.13 which clearly explains that she was obese, due to which more load would have been applied on the implant.As per ifu ¿obesity.An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself ¿, ifu also explains ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ screw breakage in general has been experienced.It does not present an unanticipated event in itself.Depending on the load application, also, depending on the patient¿s post implant behavior, on the suitable anatomical reduction, on the kind of bone breakage and depending on the course of bone healing and other factors a screw breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.A successful treatment with an implant requires sufficient bone healing during the implantation period.Implants 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.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Implant breakage may occur when the material is subjected to repeated loading and unloading resulting fatigue of material.If the loads are above a certain threshold (microscopic) cracks will begin to form on the surface.A requirement for successful treatment is that bone healing develops in a sufficient manner that the implant is relieved by load sharing / load transmission over the bone.Otherwise the implant may be subject to a fatigue fracture.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Manufacturer Narrative

Corrections to executive summary: (this product inquiry addresses implant breakage.2 (b)(4) out of 3 cases.) the reported event that locking screw, fully threaded t2 tibia ø5x42,5 mm was alleged of issue k-556 (revision) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.As per event description¿ the lady has a bmi of 36.13 which clearly explains that she was obese, due to which more load would have been applied on the implant.As per ifu ¿obesity.An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself ¿, ifu also explains ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ screw breakage in general has been experienced.It does not present an unanticipated event in itself.Depending on the load application, also, depending on the patient¿s post implant behavior, on the suitable anatomical reduction, on the kind of bone breakage and depending on the course of bone healing and other factors a screw breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.A successful treatment with an implant requires sufficient bone healing during the implantation period.Implants 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.Usually a breakage is contributed by one or more deficits, e.G.Insufficient bone healing, product damage.Implant breakage may occur when the material is subjected to repeated loading and unloading resulting fatigue of material.If the loads are above a certain threshold (microscopic) cracks will begin to form on the surface.A requirement for successful treatment is that bone healing develops in a sufficient manner that the implant is relieved by load sharing / load transmission over the bone.Otherwise the implant may be subject to a fatigue fracture.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿analysis of the t2 recon nail used with the antegrade locking mode¿ which was released in (b)(6) 2018 and is associated with the t2 recon nailing system.Within that report, postoperative complications/ adverse events were reported, which occurred between (b)(6) 2014 and (b)(6) 2017.Based on the available device and patient information and a review of complaint handling database it was revealed that the events have not been reported by the hospital or by the author of the report, therefore 15 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses septic nonunion discovered from the event of case id 62.1 out of 1 case.The pmcfr states: ¿in the second case (case 62) it was a transverse fracture (32-a) in a heavy 70 years lady.She is 1,63m in height for a weight of 96 kg (bmi of 36,13).The breakage of all three locking screws was observed.In fact a septic nonunion was observed and a revision surgery was performed 142 days after the initial surgery.All the broken screws were removed (18965050s-k05d869;18965050s-k0af9e2;18965042s-k074ffc), the nail was also removed (18471136s-k0dadeb) the medullary canal was reamed and a t2 a/r nail was then used.Antibiotics were used during 4 months.¿.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X42,5 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7710756
• MDR Text Key: 114768584
• Report Number: 0009610622-2018-00378
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540382344
• UDI-Public: 04546540382344
• Combination Product (y/n): N
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 18965042S
• Device Lot Number: K074FFC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention