MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L30MM; PLATE, FIXATION, BONE

Catalog Number	661430
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The hospital reported the following event : "during radiographic inspection at 9 months of osteosynthesis shows a pseudoseptic osteoarthritis of the left tibia with fracture of the osteosynthesis plate (placed on (b)(6) 2018 following an open fracture in the left leg).Provisional measures and actions taken: need for surgical resumption on (b)(6) 2018 with removal of the material, samples, first time mask with spacer in cement fixation by external fixator and antibiotic therapy.The device has been retained for expertise.Clinical consequences noted: need for surgical resumption and septic pseudarthrosis.".
Event or Problem Description
The hospital reported the following event : "during radiographic inspection at 9 months of osteosynthesis shows a pseudoseptic osteoarthritis of the left tibia with fracture of the osteosynthesis plate (placed on (b)(6) 2018 following an open fracture in the left leg).Provisional measures and actions taken: need for surgical resumption on (b)(6) 2018 with removal of the material, samples, first time mask with spacer in cement fixation by external fixator and antibiotic therapy.The device has been retained for expertise.Clinical consequences noted: need for surgical resumption and septic pseudarthrosis.".
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L30MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8002691
• Report Number: 0008031020-2018-00893
• Device Sequence Number: 16193739
• Product Code: HRS
• UDI-Device Identifier: 07613252580362
• UDI-Public: 07613252580362
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 661430
• Device Lot Number: L08941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 38 YR
• Patient Weight: 85