MAUDE Adverse Event Report: STRYKER GMBH K-WIRE, SMOOTH, 1.4MMX100MM; PLATE, FIXATION, BONE

Model Number	45-80200
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Open reduction and internal fixation of the left midfoot.Metalosis was observed during removal.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure; the reported device was not implanted in the primary surgery.
Event or Problem Description
Open reduction and internal fixation of the left midfoot.Metalosis was observed during removal.

• Brand Name: K-WIRE, SMOOTH, 1.4MMX100MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9555411
• Report Number: 0008031020-2020-00089
• Device Sequence Number: 19286237
• Product Code: HRS
• UDI-Device Identifier: 07613154629022
• UDI-Public: 07613154629022
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Model Number: 45-80200
• Device Catalogue Number: 45-80200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR