MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN ILIZAROV EXFIX DEV; PIN, FIXATION, THREADED

Catalog Number UNKNOWN

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Skin Infection (4544); Insufficient Information (4580)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Sigmund, i.K., ferguson, j., govaert, g.A., stubbs, d., & mcnally, m.A.(2020).Comparison of ilizarov bifocal, acute shortening and relengthening with bone transport in the treatment of infected, segmental defects of the tibia.Journal of clinical medicine, 9(2), 279.Doi: 10.3390/jcm9020279.

Event Description

It was reported that on literature review "comparison of ilizarov bifocal, acute shortening and relengthening with bone transport in the treatment of infected, segmental defects of the tibia", from the 47 patients in the sample using ilizarov, in total 30 patients had revision surgeries.Twenty-four (24) patients required revision surgery.Seventeen (17) patients during external fixation treatment: one (1) had a fibular division, four (4) a bone grafting, three (3) a freshening of docking site, four (4) a docking site realignment, two (2) a re-corticotomy due to premature fusion of the lengthening site, two (2) a bone morphogenetic protein only and one (1) a tethered pin site release due to pain.And, six (6) patients after the ilizarov external fixation removal: one (1) a external fixation reapplication, four (4) an intramedullary nail, and two (2) an ankle fusion.In addition, six (6) patients also required a revision surgery after the ilizarov external fixation removal, four (4) had a plate removal only, one (1) a plating and bone grafting, one (1) a plating and bone morphogenetic protein.Also, from those patients, twenty-two (22) patients suffered at least one superficial pin infection requiring treatment with oral antibiotics.Patient's outcome is unknown.Further information is not available.

Manufacturer Narrative

The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the literature article was reviewed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.However, it was noted via e-mail correspondence with one of the authors of the article, that ¿these complications are common events related to infection and bone healing in this patient cohort.None are related to any specific implant or product and have been described in virtually every type of external and internal fixation device.¿ no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, contamination, patient reaction, post-operative healing issue and/or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN ILIZAROV EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13636228
• MDR Text Key: 288129045
• Report Number: 1020279-2022-00937
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• 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): Required Intervention; Hospitalization