MAUDE Adverse Event Report: ZYGA TECHNOLOGY SIMMETRY SACROILIAN JOINT FUSION SYSTEM; CUTTING CURETTE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/30/2014

Event Type  malfunction  

Event Description

Zyga right angle cutting curette tip broke off in patient during right si joint arthrodesis procedure.Physician spent a considerable amount of time trying to retrieve the tip and concluded it was safer to leave it in the unobtrusive portion of the joint then to keep digging in the joint and potentially compromise the arthrodesis.

• Brand Name: SIMMETRY SACROILIAN JOINT FUSION SYSTEM
• Type of Device: CUTTING CURETTE
• Manufacturer (Section D): ZYGA TECHNOLOGY; minnetonka 55343
• MDR Report Key: 4163306
• MDR Text Key: 4790030
• Report Number: MW5038551
• Device Sequence Number: 1
• Product Code: OUR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 53