MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO; PIN, FIXATION, SMOOTH

Model Number	ST0A-19P
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: "when placing the smart toe 2 implant did not expand upon heating up.Non expanding implant was removed and exchanged for different smart toe implant that performed as expected.A surgical delay of 45min was reported.".
Additional Manufacturer Narrative
Please note correction to sections d9/h3 the product was returned, and h6 (method, results and conclusion codes).The reported event could not be confirmed, since the returned device was found to be fully functional and conforming to specifications.The device inspection revealed the following: the visual inspection showed that the implant is in a good state.No signs of damage were noticed.A functional inspection was held.The returned device was found to be conforming to specifications and fully functional.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.General aspect: ¿the smart toe has to be stored at 0°c (32°f) or below for 2 hours or more prior to implantation.The implant has to be taken out of the freezer only after site preparation is complete and ready for implantation.¿ based on the above investigation, most likely the issue is user related since no manufacturing related deficiencies were found.Although a real root cause couldn¿t be determined with the available information.
Event or Problem Description
It was reported: "when placing the smart toe 2 implant did not expand upon heating up.Non expanding implant was removed and exchanged for different smart toe implant that performed as expected.A surgical delay of 45min was reported.".

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12374426
• Report Number: 0008031020-2021-00381
• Device Sequence Number: 1206521
• Product Code: HTY
• UDI-Device Identifier: 07613252263432
• UDI-Public: 07613252263432
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K112197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: ST0A-19P
• Device Catalogue Number: ST0A19P
• Device Lot Number: H28247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2021
• 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
• Patient Sex: Unknown