MAUDE Adverse Event Report: TORNIER INC SELF DRILL CANNULA DIA7.0MM X 80MM SHORT THREAD SCREW; SCREW, FIXATION, BONE

Catalog Number	MSD-010-70-080S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a device explant surgery due to infection caused by septic arthritis from the spine that traveled throughout the lower extremities of her body.The patient received a cement spacer.The infection was discovered during the purulent drainage from the lateral aspect of the ankle.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a device explant surgery due to infection caused by septic arthritis from the spine that traveled throughout the lower extremities of her body.The patient received a cement spacer.The infection was discovered during the purulent drainage from the lateral aspect of the ankle.
Additional Manufacturer Narrative
Correction - d1, h6 (results code and conclusion code).The reported event could be confirmed, based on available information and medical expert opinion.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: "implant removed due to hematogenic infection (bacteria from another infection site in the body carried by the bloodstream to the implant).This is a patient related issue, no a device related issue." based on investigation, the root cause was attributed to a patient related issue.The failure was caused by hematogenic infection.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: SELF DRILL CANNULA DIA7.0MM X 80MM SHORT THREAD SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18738738
• Report Number: 0001649390-2024-00055
• Device Sequence Number: 17949170
• Product Code: HWC
• UDI-Device Identifier: 00846832043071
• UDI-Public: 00846832043071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: MSD-010-70-080S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male