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

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Perforation (2001)

Event Date 04/12/2023

Event Type  Injury  

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 that i have encountered specific to this implant is the expansion of the implant which perforates the phalanges.This is especially noticeable on a porotic bone in the middle phalanx".

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: "problem that i have encountered specific to this implant is the expansion of the implant which perforates the phalanges.This is especially noticeable on a porotic bone in the middle phalanx".

Manufacturer Narrative

Please note correction to h6 (device code and clinical signs code).The reported event could not be confirmed, 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.H3 other text : device disposition unknown.

• 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: 17024759
• MDR Text Key: 316207454
• Report Number: 0008031020-2023-00210
• 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,Followup
• Report Date: 09/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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
• Date Manufacturer Received: 09/15/2023
• 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