MAUDE Adverse Event Report: SYNTHES MONUMENT 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Catalog Number 352.250S

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

Patient initials are (b)(6).The patient weight is unknown.Additional product codes for this report include hrx.Udi number: (b)(4).Implant and explant dates: device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: packaged by: (b)(4) - manufacturing date: january 22, 2016 - expiration date: december 31, 2024 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.The sterility documentation was reviewed and determined to be conforming.Device 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 that a reamer/irrigator/aspirator (ria) shaft dislodged from the ria head during an intramedullary nailing procedure of the femur on (b)(6) 2016.The issue reportedly occurred as the surgeon was reaming the femur.The surgeon tried to re-connect the devices, but they would not fully seat.The ria was spun around and the tip of the shaft broke.The broken tip was removed from the patient with ease.The surgeon stopped reaming and successfully implanted the nail.There was a 30-40 seconds delay in surgery, but it was ultimately completed successfully.Concomitant devices reported: drive shaft seal (part 351.718s, lot 9973396, quantity: 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device 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.

• Brand Name: 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5659598
• MDR Text Key: 45312015
• Report Number: 1719045-2016-10408
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.250S
• Device Lot Number: 9957216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• 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: 63 YR