MAUDE Adverse Event Report: STRYKER GMBH INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 0° ANGLE FOR PIP ARTHROD; PIN, FIXATION, SMOOTH

Catalog Number ST019P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/02/2023

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 on a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient had an allergic reaction.

• Brand Name: INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 0° ANGLE FOR PIP ARTHROD
• 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: 17982352
• MDR Text Key: 326238357
• Report Number: 0008031020-2023-00369
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252263340
• UDI-Public: 07613252263340
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ST019P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• 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