MAUDE Adverse Event Report: BOSS INSTRUMENTS LTD; CUTTER, WIRE

Model Number 22" PIN CUTTER - SIDE CUT X-LARGE

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

Patient Problem No Code Available (3191)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

While cutting the excess rod, the tip of the rod cutter spine broke off and tore the dura.The dural tear was then assessed, repaired with suture and dural sealant was applied by the attending surgeon.

• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): BOSS INSTRUMENTS LTD; 104 sommerfield drive; gordonsville VA 22942
• MDR Report Key: 10343573
• MDR Text Key: 201001878
• Report Number: 10343573
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22" PIN CUTTER - SIDE CUT X-LARGE
• Device Catalogue Number: 79-0050
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other