MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / RIGHT; PLATE, FIXATION, BONE

Model Number 628227S

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "a revision surgery is performed for patient who underwent initial surgery approximately two months earlier because of a plate fracture.".

Event Description

As reported: "a revision surgery is performed for patient who underwent initial surgery approximately two months earlier because of a plate fracture.".

Manufacturer Narrative

Please note the corrections to d4 catalog # and h6 method codes.The reported event could be confirmed, since the plate is broken as complained.The device inspection revealed the following: the visual inspection has shown that the plate is broken apart, both fragments were returned for evaluation.There are different clearly visible dents on the plate surface, also in the region where the breakage occurred.These dents can be traced back to intra-operative contouring of the plate.The microscopic inspection of the fracture face has shown that the typical characteristics of a fatigue fracture can be identified at the fracture face on the left side.The origin of the crack was at the corner on the left side, in this area is also an impression mark visible.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture and finally there is in instantaneous zone, where the final fracture occurred.On the fracture face on the right side is most of the fracture face is not visible anymore, the shiny surface indicates that the fracture faces did rub against each other for a longer period of time.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.The relevant dimensions were verified during the inspection and no deviation from the specification could be detected.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.No product related issue could be detected.There was no additional information, like x-rays, operation reports, exact implant date, patient history or activity, provided.Therefore the root cause of the breakage cannot be defined.The evaluation of the plate has shown that fatigue did lead to the breakage of the device.The visible dents from contouring may also have played a certain role.In relation to the breakage and contouring following statements of the variax clavicle instructions for use can be pointed out: "post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.The implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular postoperative examinations (e.G.X-ray checks) are advisable.Contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole.Such action must be performed with stryker instruments and in accordance with the specified procedures (see operative technique)." if more information is provided, the case will be reassessed.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / RIGHT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15604915
• MDR Text Key: 301727500
• Report Number: 0008031020-2022-00543
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540687135
• UDI-Public: 04546540687135
• 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: 01/10/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 628227S
• Device Catalogue Number: 628227S
• Device Lot Number: K31865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 95 KG