MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD PROXIMAL TIBIA; LIMB SALVAGE SYSTEM

Model Number BME17907

Device Problem Problem with Sterilization (1596)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2013

Event Type  malfunction  

Event Description

It was reported by the surgeon that upon receipt of the device, it was identified that it was unsterile.The order request had specified that the component was required to be sterilised before being shipped.The hosp was able to process and sterilise the component, therefore, the procedure went ahead as planned and there was no adverse consequences for the pt.

Manufacturer Narrative

A review of the order process was carried out.It was confirmed that this hosp requires components to be sterilised prior to delivery.This has previously been carried out by siw.The investigation concluded that the customer svc rep that placed the order incorrectly marked unsterile instead of sterile.Current info is insufficient to permit a conclusion as to the cause of the reported event.Requests are being made for add'l info and a supplemental report will be provided if this info is received.Please note that this custom implant is similar to the mets smiles tks (k120992).

Manufacturer Narrative

The hospital order did not specify whether the device should be sterile as the hospital had an expectation that all implants would be supplied sterile, as previously agreed with stanmore implants (siw).The cause of the event was determined to be customer service error in that the customer order was not correctly checked for hospital specific sterility requirements.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.

Event Description

It was reported by the surgeon that upon receipt of the device it was identified that it was unsterile.The order request had specified that the component was required to be sterilised before being shipped.The hospital was able to process and sterilise the component, therefore the procedure went ahead as planned and there was no adverse consequences for the patient.This is a supplemental report to 3004105610-2014-00151 (b)(4).

• Brand Name: PROXIMAL TIBIA
• 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; borehamwood, WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 4373414
• MDR Text Key: 5112684
• Report Number: 3004105610-2014-00151
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2013
• Device Model Number: BME17907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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 Age: 25 YR