MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SMART TOE IMPLANT LENGTH 21, 10 DEGREE ANGULATED; PIN, FIXATION, SMOOTH

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 03/03/2023

Event Type  Injury  

Event Description

As reported: "the smart toes angulated implant size 21 broke.The surgeon is waiting to see if fusion will happen before removing the implant.".

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 remains implanted.If removed, it will be available.

Event Description

As reported: "the smart toes angulated implant size 21 broke.The surgeon is waiting to see if fusion will happen before removing the implant.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned and no additional information was available.With available operative notes a formal medical opinion was sought: ¿based on the available information it is hard to judge the case.It seems there were no wrongdoings.No further judgment could be done, due to lacking further information, like x-rays etc.¿ 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: UNKNOWN SMART TOE IMPLANT LENGTH 21, 10 DEGREE ANGULATED
• 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: 16908173
• MDR Text Key: 314972596
• Report Number: 0008031020-2023-00178
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/12/2023

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: 04/16/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/12/2023
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Male