MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number 628205S

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded.

Event Description

It was reported that a variax clavicle plate was inserted on (b)(6) 2023.The patient was followed up with after the procedure and it was noted that the progress of bone fusion was poor.The surgeon at the time suggested replacing the plate with a bone graft, however this was not followed through.On (b)(6) 2023 the patient felt pain and visited a different hospital where it was discovered that the plate was broken.On (b)(6) 2023 the patient underwent a revision surgery to replace the broken plate.

Event Description

It was reported that a variax clavicle plate was inserted on (b)(6) 2023.The patient was followed up with after the procedure and it was noted that the progress of bone fusion was poor.The surgeon at the time suggested replacing the plate with a bone graft, however this was not followed through.On 04-dec-2023 the patient felt pain and visited a different hospital where it was discovered that the plate was broken.On (b)(6)2023 the patient underwent a revision surgery to replace the broken plate.

Manufacturer Narrative

The received x-rays were reviewed and it can be confirmed that the plate is broken apart.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.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.The complaint was forwarded to medical affairs for review with following result: "based on the limited medical information provided i can only conclude on the x-rays (without dates) and limited patient/ hcp info.The clavicle fracture was fixed in january 2023.The fracture is a comminuted shaft fracture (only one x-ray/ ct reconstruction direction is provided, so dislocation cannot be properly judged).The post operative x-ray (only one x-ray direction again instead of two) suggests a reasonable reduction of the fracture with a plate and screws and a lag screw.There is however one fragment visible which is not reduced on the medial side of the fracture.The reduction of the remaining fracture parts cannot be properly seen because of the missing second x-ray direction.During follow up it was noticed the fracture did not heal within the normal expected time frame, it was suggested to the patient to perform revision surgery.The timepoint for this is not given.The third x-ray which is provided shows the fracture with limited healing/ union.Here (on the x-ray) a date is also missing.But the x-ray is suggestive for delayed/ non-union due to the lack of callus formation.- the hcp did notice the delayed/ non-union, the revision surgery did not take place though, on the patients wishes if correctly interpreted from the given information.In december 2023 due to newly developed pain an analysis was done, which showed the plate had broken on the medial side of the fracture.In this case there are two directions of the x-ray provided.There clearly is a lack of callus formation, suggesting a non-union 11 months after the initial surgery.One detail can be seen on these two x-rays.One of the screws on the medial side seems to be placed in the fracture, instead of in the clavicle.This screw was unable to contribute to providing stability for the healing process.It only leaves two screws on the medial side in the clavicle.The placement of this particular screw in combination with the not reduced fracture part may have contributed to the instability in the fracture and movement in the plate/ clavicle fracture area.If there is too much instability this may result in a non-union.There may also have been patient factors contributing to the non-union, these are however unknown at the time of this analysis.Plate/ screw placement and patient factors most probably have contributed to the occurrence of a non-union.The longer the non-union exist the higher the likelihood of failure/ breakage of the implant in a fatigue manner.The implants are not intended to carry the loads on the clavicle for such a long time.There are warnings and cautions available on this in the labelling.Concluding: the breakage of the clavicle plate was most probably multifactorial (user and patient related factors)." no product related issue could be detected.The plate was not returned for evaluation and the provided information is limited.Therefore it is not possible to determine the exact root cause of this event, as stated in the medical evaluation are there multiple factors that could have played a role.If more information is provided, the case will be reassessed.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 5 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18677067
• MDR Text Key: 335020858
• Report Number: 0008031020-2024-00068
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540687074
• UDI-Public: 04546540687074
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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 Catalogue Number: 628205S
• Device Lot Number: H54242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 88 KG