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

Catalog Number JTS-COIL

Device Problem Failure to Advance (2524)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190); Insufficient Information (4580)

Event Date 03/11/2020

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 (k092138).An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.

Event Description

This pi is for patient no 1: the unit stopped after 8 minutes.They tried to reverse several times.As reported: "yesterday, performed extension on 3 patients, where the jts unit didn¿t function properly.".

Event Description

This pi is for patient no (b)(6): the unit stopped after 8 minutes.They tried to reverse several times.As reported: "yesterday, performed extension on 3 patients, where the jts unit didn¿t function properly.".

Manufacturer Narrative

Updated conclusion: additional information received confirmed the patient had a successful lengthening procedure using a different jts drive unit.The jts drive unit was received back after being repaired.Reported event: an event regarding a non functioning jts drive unit was reported.The event was confirmed by product inspection.Method and results: product evaluation and results: visual inspection: pictures of the jts power unit and jts coil were taken.Visual inspection of the jts coil reported minor scratches on the frontal side.The jts power unit does not show damage on the external surface.However, the picture from the functionality test shows that a loose screw was rattling around in the power unit.Functional inspection: the unit has failed the in house functionality test.The field strength test was not performed as it was noticed during the visual inspection that a loose item was rattling around in the power unit.Clinician review: not performed as no medical records or x-ray images were provided.Product history review: a review of siw documents reported that jts drive unit 907-238 passed both annual maintenance and functionality test on 10jun2019 and 07aug2019 respectively.Complaint history review: there have been 9 other events.Conclusions: the investigation concluded that the jts drive unit was faulty.For this reason, the unit was sent for repair.The service report was provided on the 04sep2020, reporting the following: "investigation: unit has loose screws and screen had broken off.Rectification: retightened screws that was loose and replaced broken screen.Checked all other screws to make sure none were loose or broken inside the unit." the sales rep reported that the patient was successfully extended with another jts drive unit.No further info were provided.Siw will continue to monitor for trends.

Event Description

This pi is for patient no 1: the unit stopped after 8 minutes.They tried to reverse several times.As reported: "yesterday, performed extension on 3 patients, where the jts unit didn¿t function properly.".

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 (k092138) reported event: an event regarding a non functioning jts drive unit was reported.The event was confirmed by product inspection.Method and results: product evaluation and results: visual inspection.Pictures of the jts power unit and jts coil were taken.Visual inspection of the jts coil reported minor scratches on the frontal side.The jts power unit does not show damage on the external surface.However, the picture from the functionality test shows that a loose screw was rattling around in the power unit.Functional inspection: the unit has failed the in house functionality test.The field strength test was not performed as it was noticed during the visual inspection that a loose item was rattling around in the power unit.Clinician review: not performed as no medical records or x-ray images were provided.Product history review: a review of siw documents reported that jts drive unit 907-238 passed both annual maintenance and functionality test on 10jun2019 and 07aug2019 respectively.Complaint history review: there have been 7 other events.Conclusions: the investigation concluded that the jts drive unit was faulty.For this reason, the unit will be sent for repair.

• Brand Name: JTS DRIVE UNIT
• 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: 9937490
• MDR Text Key: 191694473
• Report Number: 3004105610-2020-00080
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JTS-COIL
• Device Lot Number: 907-238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other