MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIAM.24MM; SURGICAL MESH

Model Number	EBO101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device discarded.
Event or Problem Description
It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap.Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis.The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components.Components were removed and an antibiotic cement spacer was placed insitu.The patient will be need a subsequent operation after infection clears to have new components implanted.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ a review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.
Event or Problem Description
It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap.Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis.The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components.Components were removed and an antibiotic cement spacer was placed insitu.The patient will be need a subsequent operation after infection clears to have new components implanted.

• Brand Name: CEMENT RESTRICTOR DIAM.24MM
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: nathe hendricks ; 11576 memphis arlington rd; arlington, TN 38002 ; 9018679971
• MDR Report Key: 13057008
• Report Number: 3000931034-2021-00359
• Device Sequence Number: 1427422
• Product Code: FTM
• UDI-Device Identifier: 03700386922053
• UDI-Public: 03700386922053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K973453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/06/2024
• Device Model Number: EBO101
• Device Catalogue Number: EBO101
• Device Lot Number: 1400AV068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• 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: 54 YR
• Patient Sex: Male