MAUDE Adverse Event Report: STRYKER GMBH LOCKING INSERT AXSOS 5.0MM LOCKING SET; PLATE, FIXATION, BONE

Catalog Number 370003S

Device Problems Failure to Advance (2524); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

The surgeon reported that he was using an axsos ts large frag plate with the inserts and struggled to get them into the plate.He ended up using a different solution.There was no adverse patient event.Update 12/12/2017 new information received.The surgeon reported that he undertook a periprosthetic fracture fixation in a very frail and elderly lady which the initial x rays were suggestive of possible stable implant and the decision was made to fix this with a plate construct rather than revising the total hip replacement as she was very frail.When the fracture was opened, it was indeed rather more comminuted than the original imaging had suggested and there was a very obvious need for a cable plate construct at the very least.Therefore, he cabled the proximal femur with dall miles cables and applied the axsos 2 plate to the femur, precontoured it and then before siting any screws, he sited the relevant locking guides into the plate.However, the customer only had six locking guides in the whole of the department.As the surgeon sited the locking screws into the distal aspect of the femur, the locking inserts, although they had clicked in to the holes, simply backed out, converting the locking plate into a non-locking construct.This happened repeatedly.The surgeon tried with a different axsos 2 plate and once again this happened with the second plate.The reason he used the axsos 2 plate initially was so he could use the stainless steel inserts to allow him to cable over the top of the plate onto the femur once the plate was applied.The surgeon further reported that at this stage it was apparent that this construct was not going to work and he had already drilled a number of drill holes through the femur, creating further stress risers.The surgeon reported that his only option at this point was to use an axsos 3 distal femoral locking plate turned upside down.This titanium plate was not able to be contoured to the bone, therefore stood off the bone, particularly posteriorly at the greater trochanter.Also, as the surgeon was changing to a titanium plate, he had to change the stainless steel cables to vitallium cables adding time to the operation.The distal femoral plate construct was applied but the inability to angle any of the locking screws past the implant provided very poor proximal fixation.Two failed attempts to implant axsos 2 plates which had to be removed during the case.Stress risers, reduced proximal fixation.As a result, the procedure lasted four and a half hours.

Manufacturer Narrative

The reported event that the surgeon tried to use a «locking compression plate broad axsos 18 hole / l335mm 5.0mm locking set» to fix a periprosthetic fracture, but the 6 «locking inserts axsos 5.0mm locking set» backed out, and he proceeded with another «locking compression plate broad axsos 16 hole / l299mm 5.0mm locking set» but the same 6 «locking inserts axsos 5.0mm locking set» backed out again, and ended up using an ¿axsos 3 distal femoral locking plate¿, could not be confirmed, since none of the devices were returned for evaluation and no other evidences were provided.Since the reported «locking insert axsos 5.0mm locking set» was not returned, a visual inspection could not be performed.Though, it was reported that this insert was placed originally in the 1st «locking compression plate broad axsos 18 hole / l335mm 5.0mm locking set» but it backed out, and the surgeon reused it in the 2nd «locking compression plate broad axsos 16 hole / l299mm 5.0mm locking set», from where it backed out again.A deviation from the instructions could have definitely led to the reported no locking effect.Therefore, please keep in mind that the instructions for proper use should be followed at all times.As per ifu (v15013), ''ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.[¿] the implant is for single use only.[¿] single use devices cannot be reused, as they are not designed to perform as intended after the first usage.[¿] discard all damaged or mishandled implants.[¿] during the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.[¿] implants which consist of several components must only be used in the prescribed combination.'' as per op.Tech.(axsos straight plates 27076_ 982295), ''if the plate is used in a fully locked mode, plate bending is not recommended due to possible hole deformity and inability of locking insert placement.If the plate is used in a hybrid mode, the plate should only be bent above the fracture line between the compression holes.[¿] if an axsos plate is used in a locking mode, pre-operative insertion of locking inserts is required.A locking insert (4mm - ref 370002 / 5mm - ref 370003) is attached to the locking insert inserter (4mm ¿ ref 702762 / 5mm - ref 702763) and placed into the chosen hole(s) of the plate.Ensure that the locking insert is properly placed.Do not place locking inserts with the drill sleeve.[¿] locking screws can be placed in plate holes provided there is a pre-placed locking insert.The appropriate drill sleeve is threaded into the locking insert to ensure initial fixation of the locking insert into the plate.Avoid any angulation or excessive force on the drill (3.1mm or 4.3mm drill bit), as this could dislodge the locking insert.[¿] locking screws should initially be inserted manually to ensure proper alignment.If the locking screw thread does not immediately engage the plate thread, reverse the screw a few turns and reinsert the screw once it is properly aligned.Using the solid screwdriver together with the torque limiting attachment and t-handle, final tightening is performed.Maximum stability of the locking insert is achieved once the screw head is fully seated and tightened to 4nm for the 4.0mm system, respectively 6nm for the 5.0mm system.[¿] should removal of a locking insert be required for any reason, then the following procedure should be used: thread the central portion of the locking insert extractor (4mm ¿ ref 702767 / 5mm - ref 702768) into the locking insert that you wish to remove until it is fully seated.Then turn the outer sleeve/collet clockwise until it pulls the locking insert out of the plate.The locking insert must then be discarded, as it cannot be reused.A potential bending of the reported «locking compression plate broad axsos 16 hole / l299mm 5.0mm locking set», in combination with the insertion of reused/deformed «locking inserts axsos 5.0mm locking set», could definitely lead to the reported malfunction.Based on investigation, the root cause would be attributed to a user related issue.However, please note that more detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause.A review of the device history for the «locking insert axsos 5.0mm locking set» did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the devices are returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The surgeon reported that he was using an axsos ts large frag plate with the inserts and struggled to get them into the plate.He ended up using a different solution.There was no adverse patient event.Update: 12/12/2017 new information received.The surgeon reported that he undertook a periprosthetic fracture fixation in a very frail and elderly lady which the initial x rays were suggestive of possible stable implant and the decision was made to fix this with a plate construct rather than revising the total hip replacement as she was very frail.When the fracture was opened, it was indeed rather more comminuted than the original imaging had suggested and there was a very obvious need for a cable plate construct at the very least.Therefore, he cabled the proximal femur with dall miles cables and applied the axsos 2 plate to the femur, precontoured it and then before siting any screws, he sited the relevant locking guides into the plate.However, the customer only had six locking guides in the whole of the department.As the surgeon sited the locking screws into the distal aspect of the femur, the locking inserts, although they had clicked in to the holes, simply backed out, converting the locking plate into a non-locking construct.This happened repeatedly.The surgeon tried with a different axsos 2 plate and once again this happened with the second plate.The reason he used the axsos 2 plate initially was so he could use the stainless steel inserts to allow him to cable over the top of the plate onto the femur once the plate was applied.The surgeon further reported that at this stage it was apparent that this construct was not going to work and he had already drilled a number of drill holes through the femur, creating further stress risers.The surgeon reported that his only option at this point was to use an axsos 3 distal femoral locking plate turned upside down.This titanium plate was not able to be contoured to the bone, therefore stood off the bone, particularly posteriorly at the greater trochanter.Also, as the surgeon was changing to a titanium plate, he had to change the stainless steel cables to vitallium cables adding time to the operation.The distal femoral plate construct was applied but the inability to angle any of the locking screws past the implant provided very poor proximal fixation.Two failed attempts to implant axsos 2 plates which had to be removed during the case.Stress risers, reduced proximal fixation.As a result, the procedure lasted four and a half hours.

• Brand Name: LOCKING INSERT AXSOS 5.0MM LOCKING SET
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7158211
• MDR Text Key: 96815077
• Report Number: 0008031020-2018-00004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K100475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 370003S
• Device Lot Number: L12626
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other