MAUDE Adverse Event Report: MONUMENT 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number 352.253S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional classification code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported during a left femur reaming in treatment of a distal tibia non-union, the ria system was utilized for bone grafting material and the drill heads would not advance properly.The surgeon used extreme force in reaming and felt the head was dull so another head was utilized.The same issue occurred and it was difficult to advance through the bone.The surgeon switched out the shaft and then switched back to the original shaft and head to complete the procedure.A 10-15 minute surgical delay was noted due to the difficulty in reaming.No devices broke.There was no information on the initial fracture or any hardware initially implanted.Concomitant devices.Reamer shaft (part# 314.743, lot# unknown, qty 2).This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Manufacturing location: (b)(4).Manufacturing date: july 14, 2016.Expiration date: june 30, 2025.Certificate of compliance, certification of hardness for stainless steel, certificate of analysis, certificate of test and inspection sheet for incoming final inspection met specifications.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Corrected data: device is an instrument and is not implanted/explanted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A ten to fifteen (10-15) minute surgical delay was noted.

• Brand Name: 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7072460
• MDR Text Key: 93880761
• Report Number: 2939274-2017-50096
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194480
• UDI-Public: (01)10886982194480(17)250630(10)H118991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.253S
• Device Catalogue Number: 352.253S
• Device Lot Number: H118991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR