MAUDE Adverse Event Report: SYNTHES GMBH; REAMER

Model Number 03.404.021S

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

12.5mm reamer head for ria 2 had broken pieces left in patient after use.Reemer head for ria was removed along with pieces.Synthes representative was at bedside for assistance during entire procedure and during trouble shooting.12.5 mm reamer was chosen in order to ream 2 mm above the antibiotic nail size.Reaming was performed over the guidewire.Reaming was performed in order to thoroughly debride the canal.While passing the reamer down the canal, unfortunately the reamer head snapped off.The reamer head was removed with a ball-tipped guidewire, but there were four (4) individual metal pieces that remained in the canal.We were able to remove all four (4) of these metal pieces.A ball-tipped guidewire was inserted again and reaming was attempted again using a new reamer head.This time we were successful in passing the reamer down the canal.There was good resistance with passing of the reamer allowing for a thorough debridement of the canal.The ball-tipped guidewire was removed.Went on with surgery without any issue.No issue to patient.

• Brand Name: NA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; 1302 wrights lane e; west chester PA 19380
• MDR Report Key: 15378440
• MDR Text Key: 299474493
• Report Number: 15378440
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2022,08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.021S
• Device Catalogue Number: 03404021S
• Device Lot Number: 513P745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Sex: Female