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

Catalog Number UNKNOWN

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

Patient Problem Fever (1858)

Event Date 02/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Literature: double-bundle versus single-bundle anterior cruciate ligament reconstruction with allogeneic tendon via single femoral tunnel.

Event Description

It was reported that on literature review, "double-bundle versus single-bundle anterior cruciate ligament reconstruction with allogeneic tendon via single femoral tunnel", 3 patients developed a fever after surgery where an endobutton was used.The complication was treated with one week of intravenous antibiotics.The current patient status is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information in g2.Correction in g2: uncheck health professional and user facility boxes.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A clinical investigation found that without supporting clinical/medical documents, a thorough investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A relationship, if any, between the subject device and the reported event could not be determined.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: UNKN SUSPENSORY FIXATION DEV
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11557358
• MDR Text Key: 241930152
• Report Number: 1219602-2021-00624
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention