MAUDE Adverse Event Report: STRYKER GMBH KIRSCHNER WIRE FIXOS Ø0.9MM / L70MM, MARKED, TIPS TROCAR; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACH

Catalog Number	AGK09070M
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient implanted on (b)(6) 2023 with agk09070m is getting worse.It was reported that the patient is allergic to nickel.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Any documented or suspected material sensitivity is clearly contraindicated in the labelling.Since the issue cannot be confirmed due to lack of evidence like the device and patient¿s information, a definitive root cause cannot be given.However, based on available information, the issue is most probably related to user and patient related factors.It is the responsibility of the surgeon to check the allergies of a patient prior to the implantation.Also when checked the chemical composition of the kwire shows that its does contain nickel and as soon as there is knowledge of an allergy the material has to be taken out.If any further information is provided, the complaint report will be updated.

• Brand Name: KIRSCHNER WIRE FIXOS Ø0.9MM / L70MM, MARKED, TIPS TROCAR
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACH
• 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: 20074895
• Report Number: 0008031020-2024-00336
• Device Sequence Number: 11512634
• Product Code: HWE
• UDI-Device Identifier: 07613252257851
• UDI-Public: 07613252257851
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: Lay User/Patient
• Device Catalogue Number: AGK09070M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/27/2024
• 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: Unknown