MAUDE Adverse Event Report: SYNTHES (USA) LLC REAMER

Model Number SWISS 309.068 2021

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2017

Event Type  malfunction  

Event Description

Ortho surgeon, was attempting to remove a screw that had been implanted several years prior.During this attempt a "v" shaped piece of the removal tool broke in the bone.Doctor determined that it would do more harm than good to remove it.

• Brand Name: REAMER
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES (USA) LLC; 35 airport rd.; horseheads NY 14845
• MDR Report Key: 6581110
• MDR Text Key: 75669312
• Report Number: 6581110
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2017,05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SWISS 309.068 2021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR