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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Discomfort (2330); Deformity/ Disfigurement (2360); Implant Pain (4561)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.The device remains implanted in the patient.
Event or Problem Description
As reported: "the implant snapped/broke and is protruding to the side of her toe and she will need a revision.Patient is very worried about going in and they have not seen any physicians yet.Patient noticed this breakage a year or two ago.Patient started noticing discomfort and protruding of implant this year.Patient followed all mobility instructions and restrictions that were provided to by the surgeon post op.Reddish inflammation around the area where protruded implant is noticeable.The toe is bent sideways towards the big toe, 2nd two from the big toe".
Event or Problem Description
As reported: "the implant snapped/broke and is protruding to the side of her toe and she will need a revision.Patient is very worried about going in and they have not seen any physicians yet.Patient noticed this breakage a year or two ago.Patient started noticing discomfort and protruding of implant this year.Patient followed all mobility instructions and restrictions that were provided to by the surgeon post op.Reddish inflammation around the area where protruded implant is noticeable.The toe is bent sideways towards the big toe, 2nd two from the big toe".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design-related problems were unable to be identified as the lot number was not communicated.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.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: 16678073
• Report Number: 0008031020-2023-00129
• Device Sequence Number: 12396953
• Product Code: HTY
• UDI-Device Identifier: 07613252263418
• UDI-Public: 07613252263418
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: ST0A-16P
• Device Catalogue Number: ST0A16P
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 77 KG