MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS DRIVE UNIT SET; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number JTS-DRIVE-UNIT

Device Problems Material Frayed (1262); Operating System Becomes Nonfunctional (2996); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Please note that this event is related to a jts drive unit which is used in conjunction with the jts non-invasive extendible implant ((b)(4)).Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported regarding a jts drive unit: "kindly note that we used the above mentioned device and it did not work properly and there was weird noise and there is an error on the internal screen code err 50.0.".

Event Description

As reported regarding a jts drive unit: "kindly note that we used the above mentioned device and it did not work properly and there was weird noise and there is an error on the internal screen code err 50.0.".

Manufacturer Narrative

Reported event: an event regarding a non functional jts drive unit was reported.The event was confirmed by product inspection.Method & results: device evaluation and results: visual inspection: pictures of the jts power unit, jts coil, and documentation were taken.Visual inspection of the jts power unit reported showed no signs of damage.On the side of the unit the label reporting annual maintenance is present and in date.The body of the jts coil also did not show damage, however 1 directional arrow on the front of the unit was peeling and was hard to visualize.The power cord for the jts coil was damaged, the wiring appeared exposed and appeared frayed.Both the magnetic coil and the power unit console share the same serial number ¿(b)(6)¿ and both devices state the date of manufacture is ¿nov-13¿.Functional inspection: functionality test was performed on the (b)(6) 2021 at siw.It was reported no test were performed as "bare wires were found coming out of the magnet unit cable", the drive unit did not pass the functional inspection.The jts drive unit has been sent for repair.Clinician review: no medical records were received for review with a clinical consultant device history review: the last annual maintenance was performed on the (b)(6) 2021.The unit passed the annual maintenance without any reported discrepancies.Complaint history review: there have been no other events for the serial number referenced.Conclusion: an event regarding malfunction of a jts drive unit was reported.The event was confirmed by product inspection.The functional inspection determined that no test were performed as "bare wires were found coming out of the magnet unit cable".The drive unit did not pass the functional inspection.The jts drive unit has been sent for repair.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: JTS DRIVE UNIT SET
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• MDR Report Key: 11679004
• MDR Text Key: 245809105
• Report Number: 3004105610-2021-00064
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JTS-DRIVE-UNIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 70