MAUDE Adverse Event Report: CAREFUSION CURETTE C-L ANGLD GOLD CS#2-0 10IN; INSTRUMENT, SURGICAL, NON-POWERED

Model Number U-0166

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Tissue Damage (2104); Rupture (2208)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4): should additional information be received a follow-up emdr will submitted.

Event Description

The customer stated via email that they received the following complaint from end user, "surgeon, dra.(b)(6), reported that during a recent surgery the curette got broken, which means that took two more hours looking for the head of the curette.Besides, the interlaminar implant couldn't be placed because was necessary to remove the spinous process to find the head of the curette, leaving out the possibility of placing the implant." additional information received 17 sep 2015: the customer reported, the event required additional radiation exposure to find the head of the curette.There were extra shots with the arm in c position, for both the procedure and for locating and removing the fragment.It became necessary to remove and extract the spine apophysis, since the fragment was shifted after this and was very difficult to access due to the limited space.It was required to perform a laminectomy which was not scheduled to find the head of the curette.The patient in the immediate postoperative period did not have any alteration.Was not possible the arthrodesis due to lack of spine apophysis.There was also damage in the spinal canal (rupture) due to several attempts to extract the head, plus surgery took more than two hours.The procedure was a decompression of spinal canal due to stenosis.Microdiscoidectomia + + posterior fusion with laminectomy with coflex bisegmental.The plan was two coflex in two levels, but only one in the other space was necessary to remove the spinous process and that prevented to place the second implant.It has not yet been evaluated in outpatient.The patient hasn't been in follow up control, we will inform the current state.

Manufacturer Narrative

(b)(4): one u-0166 curette c-l angld gold cs#2-0 10in was reported as breaking at the tip during a surgery procedure.The sample reported was not returned, evaluations and a thorough investigation follow-up could not be performed.No specific information was given on how the curette tip possibly broke off.Root cause could not be determined due to no sample returned.Customer did not communicate the lot code of the sample, hence a dhr review could not be performed.Personnel awareness was performed on the customer complaint description with the aid of the current print and work instructions.

Manufacturer Narrative

(b)(4).The information initially reported was incorrect.The common device name, product code, and 510k number has been corrected and updated.Should additional information be received a follow-up emdr will submitted.

• Brand Name: CURETTE C-L ANGLD GOLD CS#2-0 10IN
• Type of Device: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200 INC (ST. LOUIS); 5 sunnen dr; st. louis 63143
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5093837
• MDR Text Key: 26410927
• Report Number: 1923569-2015-00019
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: U-0166
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other