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

Model Number	626984
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0008031020-2022-00146
• Device Sequence Number: 14695927
• Product Code: HRS
• UDI-Device Identifier: 07613327170917
• UDI-Public: 07613327170917
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 79 KG