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

Catalog Number	ST0A16P
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2024
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.
Event or Problem Description
As reported by the rep: "implants expanded immediately after taking out from the packaging so the implant could not be inserted." the customer confirmed that the implants were stored at 0 degrees celsius, or below, for a minimum of 2 hours before the procedure and were only removed from cold storage at the time of implanting, and not prior.The surgeon had to switch to inserting a temporary guidewire to treat the patient¿s hammertoe.This was different to what was planned but was the only way to stabilize the joint.
Event or Problem Description
As reported by the rep: "implants expanded immediately after taking out from the packaging so the implant could not be inserted." the customer confirmed that the implants were stored at 0 degrees celsius, or below, for a minimum of 2 hours before the procedure and were only removed from cold storage at the time of implanting, and not prior.The surgeon had to switch to inserting a temporary guidewire to treat the patient¿s hammertoe.This was different to what was planned but was the only way to stabilize the joint.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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 photo showing a freezer and the temperature of -1.3 degrees celsius displayed on the thermometer was received for inspection.However, this did not bring any useful information for the investigation.The root cause of the event could not be determined.According to the information provided, the conditions of storage of the device where respected, however, it is impossible to confirm this.Furthermore, it was communicated by the sales representative that the implant was stored in the freezer at a temperature of -13 degrees celsius, however, -1.3 degree celsius seems to be displayed on the photo received.In spite of this contradictory information, both temperatures are according to the instructions of storage.It must also be noted that no similar complaint has been previously opened for this catalog.The manufacturing documents of this lot were reviewed and there was no indication of possible manufacturing or material related issue.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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 ; 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: 20286294
• Report Number: 0008031020-2024-00497
• Device Sequence Number: 7301009
• Product Code: HTY
• UDI-Device Identifier: 07613252263418
• UDI-Public: (01)07613252263418(17)290131(10)AG1819
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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 Catalogue Number: ST0A16P
• Device Lot Number: AG1819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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