MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM; PLATE, FIXATION, BONE

Catalog Number 661030

Device Problem Fracture (1260)

Patient Problem Arthritis (1723)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.".

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.

Event 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 18/01/2018 following an open fracture in the left leg).Provisional measures and actions taken: need for surgical resumption on 21/09/2018 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.".

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8002708
• MDR Text Key: 124955911
• Report Number: 0008031020-2018-00899
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252579809
• UDI-Public: 07613252579809
• Combination Product (y/n): N
• PMA/PMN Number: K181091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 661030
• Device Lot Number: V50455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 85