MAUDE Adverse Event Report: SYNTHES USA; REAMER

Device Problem Component Falling (1105)

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

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown reamer rod.Part#, lot# and udi # is not available.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown reamer rod.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 that on an unknown date, during the surgery, upon inserting corail implant (non-synthes) it was observed that the implant was getting held up distally.The surgeon decided to ream the femoral canal distally.The reamers that were available were the synthes reamers.The ball tip guide wire was not used.The surgeon reamed with 10.5mm reamer and decided to ream once more with the 11.5mm reamer.Upon exiting, the reamer head disengaged in the femoral canal.The surgeon tried to reattach the reaming rod to the head but pushed the reamer head distally into the femur.The surgeon decided that the best alternative was to leave the reamer head in the femoral canal.The corail femoral implant and head were implanted and incision was closed.Patient and surgery outcome was not reported.This report is for one (1) unknown reamer rod.This is report 2 of 2 for (b)(4).

• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6178121
• MDR Text Key: 62544595
• Report Number: 2520274-2016-15687
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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