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 Problems Pain (1994); Rupture (2208); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (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.

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.His wound healed well after two weeks, so the sutures were removed in an outpatient department, and knee flexion was encouraged.Forty days after the operation, the patient came back and complained of tibial wound rupture for one day after a 1-week history of swelling and pain over the anterior aspect of the proximal tibia.Knee examination showed a 1-cm rupture in the tibial wound without obvious redness and effusion, but with focal soft-tissue swelling and moderate tenderness around the wound.The knee joint also had no obvious swelling.Laboratory evaluation revealed no systemic signs of infection, with an esr of 35 mm/h, crp of 2.9 mg/l, and wbc of 6.9 × 109/l.The knee joint fluid evaluation revealed no signs of infection, with a nucleated cell count of 900 × 106/l.The joint fluid smear of bacterium and fungus was negative.The mri scan revealed the intact screw extrusion from the tibial tunnel to subcutaneous tissue.Surgery was performed to remove the screw.When the wound rupture was incised and enlarged, the screw was found in the subcutaneous tissue surrounded by a small amount of clear fluid.The whole screw was removed, and its surrounding soft tissue was fetched for germiculture.After the debridement of the adjacent soft-tissue and tibial tunnel, sufficient irrigation was performed, and a vacuum sealing drainage dressing (vsd) covered the wound with a continuous negative pressure suction to promote healing.Vsd was removed after three days, and wound dressing was performed every three days.The cultures of preoperative joint fluid and intraoperative soft tissue were both negative.Therefore, he was discharged from the hospital with a smoothly healed wound two weeks postreoperation.After two years, he recovered uneventfully, with a knee joint range of motion of 120° of flexion to 0° of extension.The lachman test was positive, but the pivot-shift test negative.He was able to return to simple sport activities, such as jogging, without continued symptoms.The mri scan showed a continuously regenerating acl.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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: 15601483
• MDR Text Key: 301721485
• Report Number: 1219602-2022-01526
• 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: 05/10/2023

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: 05/09/2023
• 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; Other; Hospitalization
• Patient Age: 18 YR
• Patient Sex: Male