MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW AXSOS 3 TI Ø6.0MM / L70MM / FULL THREAD; PLATE, FIXATION, BONE

Catalog Number	608070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Injury (2348)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital re-sterilized the implant and cut off parts to modify for the patient.The surgery was then completed successfully with no further information available.Therefore the device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
This pi is for the two axsos screws.Primary procedure, left custom heavy pelvis.It was reported that after implanting the replacement pelvis and two axsos screws, the surgeon noticed excessive bleeding and had to remove the devices to find the source.The surgeon decided to abort the procedure and closed the patient.Post-operatively, the patient is stable.The surgeon reported his belief that in removing scar tissue (patient diagnosed with ewings sarcoma and had a previous procedure to resect bone), he may have hit a vessel which caused the bleeding.Rep confirmed there are no allegations against the implants, and reported that no further information is available.Update 19/nov/2019: hospital re-sterilized the implant and cut off parts to modify for the patient.The surgery was then completed successfully with no further information available.

• Brand Name: CANCELLOUS SCREW AXSOS 3 TI Ø6.0MM / L70MM / FULL THREAD
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9421255
• Report Number: 0008031020-2019-02041
• Device Sequence Number: 533980
• Product Code: HRS
• UDI-Device Identifier: 07613252579014
• UDI-Public: 07613252579014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 608070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/06/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 143