MAUDE Adverse Event Report: CAREFUSION, INC S-L SIDE LOADING RET HAND-AL.; RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Catalog Number T-1295

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

The surgeon was not able to hold the blade because the locking retractor handle stuck while tightening the handle.The surgeon held the blade by hand and set the retractor.Due to this event the surgery was prolonged about 10 minutes.Additional information received on 13aug2019, the customer reported the surgeon held the blade by hand and set the retractor for the acdf.It was unknown: if the device got stuck while threading the blade, if oil was used to lubricate metal on metal threading, any patient information, if there was any patient injury, or if the procedure was completed as planned.

Event Description

The surgeon was not able to hold the blade because the locking retractor handle stuck while tightening the handle.The surgeon held the blade by hand and set the retractor.Due to this event the surgery was prolonged about 10 minutes.Additional information received on 13aug2019, the customer reported the surgeon held the blade by hand and set the retractor for the acdf.It was unknown: if the device got stuck while threading the blade, if oil was used to lubricate metal on metal threading, any patient information, if there was any patient injury, or if the procedure was completed as planned.

Manufacturer Narrative

(b)(4): this event was inadvertently reported to us twice.This is a duplicate of 1923569-2019-00007, please cancel this report.

• Brand Name: S-L SIDE LOADING RET HAND-AL.
• Type of Device: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 8917309
• MDR Text Key: 207342494
• Report Number: 1923569-2019-00009
• Device Sequence Number: 1
• Product Code: GZT
• Combination Product (y/n): N
• PMA/PMN Number: K964402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: T-1295
• Device Lot Number: K16
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other