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

Model Number MSCOL/R30C

Device Problems Device Issue (2379); Incorrect Device Or Component Shipped (2962)

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

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

The returned product was visually inspected against the dispatch note that was sent with the kit.This inspection confirmed that mscol/r30c was present with the incorrect batch number.Batch number b13583 was physically in the kit while batch number b51884 was on the dispatch note.This inspection also confirmed that msfshft/150 was identified on the dispatch note but was not present in the kit.Ncr 059 has been raised to address this event further.

Event Description

It was reported that a distal femur was shipped on the (b)(6) 2016.When the hospital checked the kit on arrival it was identified that item msfshft/150 was missing although it was listed on the dispatch note.Item mscol/r30c; the batch number on the box didn't match the batch number on the dispatch note.(b)(4).

Manufacturer Narrative

The investigation concluded that the root cause of this event was due to a human error relating to the dispatch of a mets kit.On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.However on completion of the investigation into the reported event it can now be concluded that the incident does not meet the three basic reporting criteria referenced in 21 cfr part 803 as a marketed device did not cause or contribute to a death or serious injury, or a marketed device has not malfunctioned where the malfunction of the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Product surveillance will continue to monitor for trends.Corrected from crc# df 4611 / kit# kdf7 to mscol/r30c.

Event Description

It was reported that a distal femur was shipped on the (b)(6) 2016.When the hospital checked the kit on arrival it was identified that , item msfshft/150 was missing although it was listed on the dispatch note , item mscol/r30c; the batch number on the box didn't match the batch number on the dispatch note.This is a supplemental report to 3004105610-2016-00099 ((b)(6)).

• Brand Name: DISTAL FEMUR METS
• 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: 6106009
• MDR Text Key: 60089018
• Report Number: 3004105610-2016-00099
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K121029
• 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: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSCOL/R30C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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