MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JET-X EXFIX DEVICE; PIN, FIXATION, THREADED

Catalog Number UNKNOWN

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

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Type  Injury  

Event Description

It was reported that the patient underwent a manipulation of left knee under anesthesia thirty-two (32) weeks post the jet-x application due to arthrofibrosis.The jet-x system was initially applied to treat a tibial fracture and it was removed at post operative day fifty six (56) because the fracture was already healed.It is unknown if the ex fix device is related to arthrofibrosis, but its potential contribution cannot be discarded.The current state of health of the patient is unknown.This information was provided as part of a multidevice data collection activity associated to the jet-x pmcf study, therefore, no further details are available at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no further details are available currently, therefore, the relationship between the jet-x and the reported adverse cannot be confirmed.Consequently, 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; therefore, 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.Some potential probable causes that could contribute to the reported event have been identified as post-operative healing issue and/or patient condition.The contribution of the device 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 device 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: JET-X EXFIX DEVICE
• 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: 15070546
• MDR Text Key: 296285681
• Report Number: 1020279-2022-03372
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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?: No
• Date Manufacturer Received: 08/12/2022
• 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
• Treatment: PN: 71062300/LOT: UNKNOWN.; PN: 71065401/LOT: UNKNOWN.; PN: 71065402/LOT: UNKNOWN.; PN: 71067372/LOT: UNKNOWN.; PN: 71067374/LOT: UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female