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

Catalog Number UNKNOWN

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

Patient Problem Muscular Rigidity (1968)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Doi: 10.1016/j.Arthro.2004.10.017 literature article: prodromos, c.C., han, y.S., keller, b.L., & bolyard, r.J.(2005).Stability results of hamstring anterior cruciate ligament reconstruction at 2-to 8-year follow-up.Arthroscopy: the journal of arthroscopic & related surgery, 21(2), 138-146.

Event Description

It was reported that on literature review "stability results of hamstring anterior cruciate ligament reconstruction at 2- to 8-year follow-up", after surgery with an endobutton, 1 patient experienced knee stiffness which required a revision surgery.No further information is available.

Manufacturer Narrative

H10: h3, h6: 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.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.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 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: UNKNOWN SUSPENSORY FIXATION DEVICE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12474146
• MDR Text Key: 271465405
• Report Number: 1219602-2021-02016
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention