MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP K-WIRE, TROCAR PTS. 4.0'' X .035''; PIN, FIXATION, SMOOTH

Catalog Number	1346001000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device implanted.
Event or Problem Description
It was reported that after hand surgery, the patient reported a potential allergic reaction to the implanted k-wire in their thumb.Antibiotics were administered for potential infection.It was also reported that the initial procedure was completed successfully.
Additional Manufacturer Narrative
D4: full udi is not available due to missing lot #.H6: the quality investigation is complete.
Event or Problem Description
It was reported that after hand surgery, the patient reported a potential allergic reaction to the implanted k-wire in their thumb.Antibiotics were administered for potential infection.It was also reported that the initial procedure was completed successfully.

• Brand Name: K-WIRE, TROCAR PTS. 4.0'' X .035''
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 19225040
• Report Number: 3015967359-2024-00995
• Device Sequence Number: 8105590
• Product Code: HTY
• UDI-Device Identifier: 34546540029479
• UDI-Public: 34546540029479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1346001000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female