SMITH & NEPHEW, INC. UNKNOWN PEEK INTERFERENCE SCREW; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Catalog Number UNKNOWN |
Device Problem
Expulsion (2933)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case-(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.
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Event Description
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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 a peek interference screw.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.
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Manufacturer Narrative
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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, complaint history review, risk management review, and an instructions for use/device labeling 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.A clinical review states 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.
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