MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L50MM; PLATE, FIXATION, BONE

Model Number	661050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "dr.Used the ankle fusion plate to fuse the tibiotalar joint.We put in 7 screws (4.0 locking qty 4, 3.5 cortex screws qty 2, 6.5 cannulated screw qty 1) into the plate.The patient came back to clinic today 1/28 in some pain and dr.Took and x-ray and we discovered 3 screws have broken and the plate is sitting of the bone." additional information: screws broke sometime between 12/17-1/28.The patient came in on 1/28 with pain and swelling of her ankle.We determine through x-ray that the screws failed.Before she was weight bearing as tolerated and now she is in a cam boot.No further action has been planned at the moment.Her activity level is low and she is diabetic.She has had previous surgeries on same foot 6 years ago.Orif or righty tri mal and syndesmotic screws and then hardware removal.Her diabetes is poorly controlled a1c is high.
Additional Manufacturer Narrative
The reported event could be confirmed, since x-rays were provided and show three broken screws.No devices were returned, but the x-rays show that the two most proximal screws on the plate broke, as well as the screw below the cannulated 6.5mm one.Since medical information about the patient were provided, the opinion of a medical expert was requested: " unfortunately the provided information is very limited.The x-ray provided is only in one direction and the patient information is limited as well.[.] in october 2020 the ankle fusion system was placed, in jan 2021 it was noticed that the proximal screws were broken.In the lateral x-ray which is provided it is clear the cortical 3.5 screws broke and 1 tibial locking screw.From a biomechanical perspective it could be argued if this construct contributed to the failure of the screws.Distally the construct is very rigid with only locking screws and the additional cp screw.Proximally the construction only relies on the 2 cortical screws.The early (full) weightbearing in this obese patient may have led to a lot of additional stress on the proximal part of the plate, especially if she still had (unwilling) movement in her ankle while walking.This additional stress and (micro-)movement on the proximal part of the plate may have caused the screws to fail from proximal until even the locking screw in the tibia broke.It seems that also the cp screw was retracted a bit into the (to be) fused joint.As always the failure of the construct is a multifactorial problem, in this case there are patient and construct factors that both may have contributed to the breakage.[.]" based on investigation, the root cause was attributed to various factors amongst which we can name a rigid construct and an improper weight bearing conditions.A review of the device history was not possible because the lot number was not communicated.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 device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "dr.Used the ankle fusion plate to fuse the tibiotalar joint.We put in 7 screws (4.0 locking qty 4, 3.5 cortex screws qty 2, 6.5 cannulated screw qty 1) into the plate.The patient came back to clinic today 1/28 in some pain and dr.Took and x-ray and we discovered 3 screws have broken and the plate is sitting of the bone." additional information: screws broke sometime between 12/17-1/28.The patient came in on 1/28 with pain and swelling of her ankle.We determine through x-ray that the screws failed.Before she was weight bearing as tolerated and now she is in a cam boot.No further action has been planned at the moment.Her activity level is low and she is diabetic.She has had previous surgeries on same foot 6 years ago.Orif or righty tri mal and syndesmotic screws and then hardware removal.Her diabetes is poorly controlled a1c is high.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L50MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11376333
• Report Number: 0008031020-2021-00068
• Device Sequence Number: 3865901
• Product Code: HRS
• UDI-Device Identifier: 07613252579908
• UDI-Public: 07613252579908
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 661050
• Device Catalogue Number: 661050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 109