MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN MODULAR RAIL SYSTEM EXFIX DEV; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNKNOWN

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

Patient Problems Bone Fracture(s) (1870); Malunion of Bone (4529); Skin Infection (4544)

Event Date 12/18/2021

Event Type  Injury  

Event Description

It was reported that on literature review "comparison of intramedullary magnetic nail, monolateral external distractor, and spatial external fixator in femur lengthening in adolescents with congenital diseases", after using a modular rail systemor a taylor spatial frame, seven (7) patients presented pin-site superficial infection, one (1) patient presented malunion union and three (3) patients presented fracture post frame removal.It is unknown how this adverse events were treated.Further information is unknown.

Manufacturer Narrative

Internal complaint reference: (b)(4).Pietrzak, s., grzelecki, d., parol, t., & czubak, j.(2021).Comparison of intramedullary magnetic nail, monolateral external distractor, and spatial external fixator in femur lengthening in adolescents with congenital diseases.Journal of clinical medicine, 10(24), 5957.Doi: 10.3390/jcm10245957".

Manufacturer Narrative

Results of investigation: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any relevant clinical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the products 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, traumatic injury, procedural/user error, surgical/post operative complications, healing issues, surgical technique 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 products 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 MODULAR RAIL SYSTEM EXFIX DEV
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13636202
• MDR Text Key: 286350516
• Report Number: 1020279-2022-00935
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/08/2022

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: 04/01/2022
• 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
• Treatment: UNKN TAYLOR SPATIAL FRAME EXFIX DEV
• Patient Outcome(s): Required Intervention; Hospitalization; Other