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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 20 HOLE / L329MM PLATE, FIXATION, BONE

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STRYKER GMBH PROXIMAL LATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 20 HOLE / L329MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627350S
Device Problems Bent (1059); Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2017
Event Type  malfunction  
Manufacturer Narrative
The reported event that the ¿proximal lateral tibia plate axsos 3 ti for right tibia 20 hole / l329mm¿ was unstable and bent, during the surgery, could be confirmed, since the device was returned for evaluation, and it was confirmed to be slightly bent. The device inspection revealed that the plate is used, with minor scratches around its surface, and many of the round holes, in the long shaft, have deformed threads. This indicates the usage of screws. The short part of the plate also has deformed screw holes. The plate follows the original shape of the manufacturing drawing but is slightly bent, most likely due to usage. The inspection protocol for the reported implant was reviewed and did not indicate any deviation from the specifications. Therefore it was not delivered deformed, but became like that upon usage. It was reported that during screwing in the fix-angled screw the reported ¿proximal lateral tibia plate axsos 3 ti for right tibia 20 hole / l329mm¿ became unstable and bent, and that the plate was not contoured/reshaped during the procedure. As per op. Tech. (axsos-st-1_2015-8380), ¿plate contouring will affect the ability to use the targeting device for percutaneous screw placement. It is therefore not recommended. If for any reason the plate needs intraoperative contouring, it is recommended to perform shaft fixation using the conventional screw insertion technique without the use of the targeting device. It is recommended that screw insertion be performed using the soft tissue protection sleeve to ensure proper screw alignment in the core hole. Correct screw alignment is important to avoid unintentional thread engagement, which may lead to plate lifting during screw insertion. Do not use power for final insertion of locking screws. It is imperative to engage the screw head into the plate using the torque limiter. Ensure that the screwdriver tip is fully seated in the screw head, but do not apply axial force during final tightening. '' a deviation from the proper usage instructions, could definitely lead to a lifting/bending of the plate, during the procedure. 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. Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments. Single use devices cannot be reused, as they are not designed to perform as intended after the first usage. Avoid surface damage of 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. ¿ based on the investigation, the root cause was attributed to a user related issue due to a mishandling of the device, during insertion of the screws. A review of the device history for the reported lot 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 any further information is provided, the investigation report will be updated.
 
Event Description
This event occurred during primary surgery. Plate was unstable and bent. Plate was removed and a t2 tibia nail was used. Plate and screw will be returned. No adverse consequences to the patient.
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
This event occurred during primary surgery. Plate was unstable and bent. Plate was removed and a t2 tibia nail was used. Plate and screw will be returned. No adverse consequences to the patient.
 
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Brand NamePROXIMAL LATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 20 HOLE / L329MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6595028
MDR Text Key207301980
Report Number0008031020-2017-00331
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K123964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue Number627350S
Device Lot NumberV27288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2017 Patient Sequence Number: 1
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