MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 5.0MM / L75MM; SCREW, FIXATION, BONE

Catalog Number	661175
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Note: surgeon reported that infection occurred after mole removal performed by a dermatologist.(unknown if clinically confirmed or if infecting microorganism was identified).Nevertheless it was reported that the dlf plate and 11 screws were explanted.No further information will be released by the hospital or surgeon.Based on the given information, the root cause is likely patient related.No failure of the used implants could be determined as it is unknown if clinically confirmed or if infecting microorganism was identified.Note more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was deemed to be unnecessary.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Retained by hospital.
Event or Problem Description
It was reported that all hardware in the patient's left femur was removed due to infection.Surgeon reported that infection occurred after mole removal performed by a dermatologist.A dlf plate and 11 screws were explanted.

• Brand Name: LOCKING SCREW AXSOS 3 TI 5.0MM / L75MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8767112
• Report Number: 0008031020-2019-00790
• Device Sequence Number: 1937434
• Product Code: HWC
• UDI-Device Identifier: 07613252580232
• UDI-Public: 07613252580232
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: Lay User/Patient
• Device Catalogue Number: 661175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/08/2019
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 65