MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SMART TOE II IMPLANT; PIN, FIXATION, SMOOTH

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

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 in a supplemental report.H3 other text : device disposition unknown.

Event Description

As reported: "surgeon reported his recollective feedback on 100 surgical cases with use of all available implant versions.His response is somewhat mixed ¿ while many items, including questions related to the bone consolidation rate and to the fulfilment of intraoperative performance characteristics were answered favorably, surgeon indicated that two of the queried adverse event types (¿bone fracture¿ and ¿implant breakage¿) were observed at a ¿more than expected¿ rate; in addition, one or more of the observed adverse events, as well as one or more of the performed revision or implant removal surgeries were directly related to the smart toe ii implants, whereas not all of these events were reported to stryker on an individual, case-by-case basis (patient level)" update received from surgeon on 03 may 2023: "problem we may encounter is a position defect in the intermediate phalanx with secondary displacement and most of the time pseudo arthrodesis or arthrodesis with a plantar flexion of the joint greater than the one initially set.".

• Brand Name: UNKNOWN SMART TOE II IMPLANT
• Type of Device: 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: 16906513
• MDR Text Key: 314947630
• Report Number: 0008031020-2023-00176
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention