MAUDE Adverse Event Report: STRYKER GMBH SLIM Y-PLATE, 4 SHAFT HOLES (T8) VARIAX2 FOOT; PLATE, FIXATION, BONE

Model Number 626984

Device Problems Break (1069); Crack (1135); Fracture (1260)

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

Event Date 01/14/2022

Event Type  Injury  

Event Description

Patient had a stryker plate put into his foot.About 2 months ago he started experiencing pain and discomfort.He reported that as per the surgeon, the plate was 'cracked in half'.Patient describes a pinching and burning pain in their toe.The big toe is inflamed and is tender to the touch.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted.

Event Description

Patient had a stryker plate put into his foot.About 2 months ago he started experiencing pain and discomfort.He reported that as per the surgeon, the plate was 'cracked in half'.Patient describes a pinching and burning pain in their toe.The big toe is inflamed and is tender to the touch.X-rays showed that the toe was not completely fused and the plate was broken in half.This is on the patient's right big toe.

Manufacturer Narrative

Correction: please refer to b2, h6 mdr codes (device, method, results, conclusion & health impact code) the reported event could be confirmed with the x-rays provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Since x-rays were provided, a formal medical opinion was sought from an experienced medical expert as below: ¿[¿] there are some points which could have contributed to the failure.The plate is not foreseen to overtake the load of the mcp joint for a long time.As the whole body weight is on the joint and thus the plate, this is not possible.Non-union is more likely in the case of a revision.Very accurate preparation of the joint to allow arthrodesis with bone substitution and careful removal of the whole cartilage is necessary and still non-union is common.Whether this has been done in the provided case cannot only be assessed via x-ray.However, in this case the plate alone did not provide enough stability and it ended up in the breakage.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused due to the non-union of the mcp joint that was not achieved in time and the plate broke.With the very high load in the joint this is not uncommon.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SLIM Y-PLATE, 4 SHAFT HOLES (T8) VARIAX2 FOOT
• 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: 14050877
• MDR Text Key: 288851685
• Report Number: 0008031020-2022-00146
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327170917
• UDI-Public: 07613327170917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 626984
• Device Catalogue Number: 626984
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 79 KG