MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SUSPENSORY FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyst(s) (1800)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after an initial acl reconstruction procedure performed approximately 3 years ago using an endobutton fixation system, a large cyst was identified on the femoral side where the device was fixated.Surgeon opened and removed the endobutton along with significant cyst material along the femoral tunnel.Biopsies were taken and sent to lab; surgeon commented that it looked like infected tissue.Current status of the patient is unknown.Further details are not available.

Manufacturer Narrative

H10 h6 the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.A complaint history review found similar reported events.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided, and thus, an instructions for use review could not be conducted.Insufficient product identification information was provided, and thus, a risk management review could not be conducted.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided this complaint will be re-evaluated.The complaint was not confirmed.Factors that could have contributed to the reported event include a biological response unrelated to the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKNOWN SUSPENSORY FIXATION DEV
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14000792
• MDR Text Key: 288600676
• Report Number: 1219602-2022-00494
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention