MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT; PLATE, FIXATION, BONE

Model Number 628008S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported the most medial screw loosened from 3 weeks after the operation, and finally the lock was released and all the implants came off.On (b)(6) 2021, revision surgery was performed and it was replaced with a long plate.

Manufacturer Narrative

The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate and locking screw present significant signs of wear or scratches.The plate returned contains 4 universal holes, and 4 oblong holes.When the universal holes are inspected more thoroughly, it can be noticed that two of them show traces of metal deformation.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.The optech instructs user that: ¿made of titanium alloy (ti6al4v) and treated with a type ii anodization, these plates are designed to carry the loads that are required of them while remaining low profile.Additionally, if locking is required, the 3.5mm and 2.7mm locking screws can be locked within a 30° cone in any circular hole.When a screw is driven into a plate hole, the locking threads on the underside of the screw engage the circular ¿lip¿ in the hole.The circular holes in the locking plates provide an option for locking and nonlocking screws.Only non-locking screws may be placed in the oblong holes of the plate.Circular holes accept either locking or non-locking screws.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿the clavicle fracture has been treated with a plate.Three screws on each site of the fracture.This is usually sufficient if the bone stock is not compromised.However, in this case the screw medial of the fracture line has been placed pretty close to the fracture-and it seems as if there was some communition where the screws were placed.Therefore, there was a lack of stability at that position and that could have contributed to the loss of fixation and loosening.The fracture pattern and possibly the quality of the bone may have contributed to the loss of fixation.It is known that the medial part of the clavicle sometimes shows difficulties in healing and that consolidation takes more time than at other locations.So, the root cause is the complex fracture, the fracture location and at least to some degree the choice of the implant (maybe too short for the fracture).¿ based on investigation, the root cause was primarily attributed to a patient related issue i.E.Complex fracture, the fracture location and at least to some degree the choice of the implant (maybe too short for the fracture).The fracture pattern and possibly the quality of the bone may have contributed to the loss of fixation.It is known that the middle third/part of the clavicle sometimes shows difficulties in healing and that consolidation takes more time than at other locations.If any further information is provided, the complaint report will be updated.

Event Description

It was reported the most medial screw loosened from 3 weeks after the operation, and finally the lock was released and all the implants came off.On (b)(6) 2021, revision surgery was performed and it was replaced with a long plate.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 8 HOLE / LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12318002
• MDR Text Key: 266375272
• Report Number: 0008031020-2021-00360
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540686879
• UDI-Public: 04546540686879
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113760
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 628008S
• Device Catalogue Number: 628008S
• Device Lot Number: H23225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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