MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 15MM / 0° ANGLE FOR PIP ARTHROD; PIN, FIXATION, SMOOTH

Catalog Number	ST015P
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional 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 remains in patient body.
Event or Problem Description
Ansm reported that: "patient operated on (b)(6) 2021 for arthrodesis of the 4th left toe, using a smart toe centromedullary implant.Size 15.Subsequently, the arthrodesis did not consolidate.The implant failed.It was therefore necessary to consider to perform a new arthrodesis, remove the implant and use a new toe grip centromedullary implant." (event covered under another complaint mfr report#: 0008031020-2023-00439)."the surgeon operated on the patient on (b)(6) 2023.It was totally impossible to remove the smart toe, even by releasing the proximal close.The 2 phalanges would have had to be "split open".Patient's current condition: arthrodesis had to be performed with another device.Actions taken in the care facility to manage the patient: the surgeon left the smart toe implant in place and performed arthrodesis using 2 crossed pins, one pin positioned above the implant, one pin positioned below the implant.The pins were inserted under scopic control, and the patient had to keep them in place for 6 weeks.".
Additional Manufacturer Narrative
The reported event could not be confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.If the device is returned or if any additional information is provided, the investigation will be reassessed.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
Ansm reported that: "patient operated on (b)(6) 2021 for arthrodesis of the 4th left toe, using a smart toe centromedullary implant.Size 15.Subsequently, the arthrodesis did not consolidate.The implant failed.It was therefore necessary to consider to perform a new arthrodesis, remove the implant and use a new toe grip centromedullary implant." (event covered under another complaint mfr report # 0008031020-2023-00439)."the surgeon operated on the patient on (b)(6) 2023.It was totally impossible to remove the smart toe, even by releasing the proximal close.The 2 phalanges would have had to be "split open".Patient's current condition: arthrodesis had to be performed with another device.Actions taken in the care facility to manage the patient: the surgeon left the smart toe implant in place and performed arthrodesis using 2 crossed pins, one pin positioned above the implant, one pin positioned below the implant.The pins were inserted under scopic control, and the patient had to keep them in place for 6 weeks.".

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 15MM / 0° ANGLE FOR PIP ARTHROD
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18474489
• Report Number: 0008031020-2024-00013
• Device Sequence Number: 20563881
• Product Code: HTY
• UDI-Device Identifier: 07613252263302
• UDI-Public: 07613252263302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: ST015P
• Device Lot Number: H33980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown