MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10 ANGLE FOR PIP ARTHRO; PIN, FIXATION, SMOOTH

Model Number	ST0A-16P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
It was reported that the rep was notified that a leg of the patient's smart toe implant was broken.Possible cause or contributor for the breakage was not reported to the rep.Patient has not been revised as of the time of report.
Additional Manufacturer Narrative
Correction: refer to b2, section d6a, h6 conclusion code, h6 health impact code.The reported event could be confirmed, through the additional patient medical reports that were shared.A device inspection was not possible since the affected device was not returned.The batch 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.A few preoperative and postoperative radiographs were shared.Along with that an extensive medical record of the patient was also shared.Following that, these were shared to our hcp for a medical opinion.Strictly based on the information available, the medical opinion he shared was that the fracture/luxation was temporarily fixed with k-wires successfully and that there was no need for plates and screw.The luxation was fixed after a few weeks and then the material should be taken out to allow the normal function of the tarso-metatarsal joint.Even if the plate and screws were used, they should have been removed much earlier in a timely manner.Then one could see whether further residual symptoms remain.The luxation will-on the long term-lead to alterations and arthrosis in the tarso-metatarsal joints involved.He further opined that the pain is most likely related to the devices and he would recommend extracting them, as they no longer provide any function but only interferes with normal function in the tarso-metatarsal joint.Based on the medical records and hcp¿s medical opinion, the root cause of the failure is determined to be user and patient related, but predominantly user related.Although the pain is related to the device, but it is because of its prolonged stay inside the patient rather than any deficiency in itself.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the rep was notified that a leg of the patient's smart toe implant was broken.Possible cause or contributor for the breakage was not reported to the rep.Patient has not been revised as of the time of report.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 10 ANGLE FOR PIP ARTHRO
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10116914
• Report Number: 0008031020-2020-01545
• Device Sequence Number: 11603132
• Product Code: HTY
• UDI-Device Identifier: 07613252263418
• UDI-Public: 07613252263418
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: ST0A-16P
• Device Catalogue Number: ST0A16P
• Device Lot Number: D36140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR