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

Catalog Number UNKNOWN

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

Patient Problem Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that on literature review "extra-articular migration of peek interference screw after anterior cruciate ligament reconstruction: a report of two cases", 1 patient had an acl reconstruction procedure using an endobutton.The patient recovered well and was discharged two days post-operation.Her wound healed well, and the sutures were removed in an outpatient department.Knee flexion was encouraged two weeks postoperation.The patient regained the normal range of knee motion, but she complained of discomfort in the pretibial wound six months post-operation.Physical examination revealed a bulge under the wound scar, with a firm and immobile palpable mass.The mri scan showed a part of screw extrusion from the tibial tunnel to the subcutaneous tissue.After six months, the patient complained of increased subcutaneous bulge with tenderness.The x-ray showed no tibial tunnel enlargement, while the mri scan showed that the screw was extruded out even more.Then, a second operation was performed to remove the whole screw successfully.The patient recovered well and resumed her daily activities without any discomfort.No further information is available.

Manufacturer Narrative

(b)(4).Article: fang, c.H., li, m., zhang, y.F., & liu, h.(2021).Extra-articular migration of peek interference screw after anterior cruciate ligament reconstruction: a report of two cases.Bmc musculoskeletal disorders, 22(1), 1-7.

Manufacturer Narrative

H3, 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.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 specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states a re-operation and removal of the ¿whole screw¿ was performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.It was communicated that the requested clinical documentation was not available; therefore, contributing clinical factors could not be concluded and it cannot be concluded that there was a malperformance of the s+n device.With the limited information provided, the patient impact beyond the reported events and subsequent re-operation with explantation of the whole screw cannot be determined.No further medical assessment can be rendered at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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 DOUBLE ENDOBUTTON 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: 15601584
• MDR Text Key: 301722156
• Report Number: 1219602-2022-01525
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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: 12/12/2022
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 56 YR
• Patient Sex: Female