MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD DISTAL FEMUR JTS; LIMB SALVAGE SYSTEM

Model Number PIN 20312

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem Cancer (3262)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) has been raised for for the investigation of this complaint.The investigation is ongoing and a supplemental report will be submitted upon completion.

Event Description

It was reported that the axle didn't match the design, instead of being a standard size the axle was a small one.The small axle was labelled as a standard size axle.An alternative device was available at the hospital.(b)(4).

Manufacturer Narrative

The investigation concluded that the design of the device correctly specified a standard size axle and this was communicated accurately in the general assembly drawing.A transcription error was made in the generation of the picking list and this resulted in a small size axle being incorrectly selected for this implant.The final assembly check for this implant used a generic standard size axle to check that the implant components fit correctly and did not use the actual axle that was to be supplied.The small axle which had not been used for the assembly check was then incorrectly presented as a standard axle for packing and it was therefore incorrectly packed as a standard size axle.The custom implant inspection work instruction, wi b004, has been updated, to issue no.7, to include clarification that all metal components used for the final implant assembly check are to be the actual components that will be supplied to the end user (section 6.11).No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Siw will continue to monitor for trends.Corrected data - (b)(6).Custom distal femur corrected to distal femur jts.

Event Description

It was reported that the axle didn't match the design, instead of being a standard size the axle was a small one.The small axle was labelled as a standard size axle.An alternative device was available at the hospital.This is a supplemental report to 3004105610-2016-00093 (b)(4)).

• Brand Name: DISTAL FEMUR JTS
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park; elstree, WD6 3-SJ ; UK WD6 3SJ ; 208238 650
• MDR Report Key: 6043076
• MDR Text Key: 57926772
• Report Number: 3004105610-2016-00093
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: PIN 20312
• Device Lot Number: PIN 20312
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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): Other
• Patient Age: 11 YR