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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN RONGEUR, MANUAL

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CAREFUSION, INC RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN RONGEUR, MANUAL Back to Search Results
Model Number NL3785-16
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4): one (1) nl3785-16 rhoton ball dissector 3mm 90deg 7-1/2in was reported as the complaint. The complaint sample was not received, and a sample photo was not sent. Lot code information was requested but not reported by the customer. The customer reported issue with the working end/tip breaking off during a surgical procedure. The customer notes it is a micro tool that was being used under the microscope during the surgical procedure. The broken tip nor the actual sample was returned to confirm the complaint. The broken tip was not recovered and was noted by customer to have possibly been removed by the suction device during surgical wound irrigation. Details of the sample and functionality were reviewed. The nl3785-16 is a dissector tool with a small 3mm wide tip, which is angled at 90 degrees. The product and tip is shaped from a single piece of blank steel rod, the steel material is 420 series stainless steel. During the finishing process, the tip size and neck of the 90 degree ball tip is ground down to print specifications: the neck of the tip where the bend occurs has a dimension of 0. 020 +/-. 003 inches. This is a small dimension making the tip delicate, for fine applications and surgical procedures. It is possible excessive forces were applied to the tip enough to result in breaking off; however this possibility cannot be confirmed. Finally a bright finish is applied to the tip of the instrument. It should be noted that the sample has magnetic properties due to 400 series type steel. Root cause of failure mode is not known based on limited information and no sample received for evaluations. Conclusion(s): no samples and/or sample photos were returned for evaluations and verifications. No lot code was reported for dhr review. Root cause could not be determined. Current reference processes were reviewed to indicate proper manufacturing.
 
Manufacturer Narrative
(b)(4). If further information becomes available a follow up medwatch will be submitted.
 
Event Description
Medwatch report (b)(4) states: a 2 mm right angle rhoton dissector ball micro tip broke off into the surgical field. All three methods were used (c-arm, o-arm, and microscope) to rule out if a metallic foreign body item was on the surgical field or retained in the patient. All scans were read and reported to the surgeon by the radiologist, stating nothing was retained in the patient's body. Risk management was called and the instrumentation that was broken was sent off. The broken piece could not be found on field or inside patient. It is believed it was removed by the suction device during wound irrigation. No foreign item was retained in the patient per radiologist. Minor injury to the patient was additional radiation required to try to find the device. What was the original intended procedure: cervical 5-6 and cervical 6-7 anterior cervical discectomy and fusion. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working). Patient information: (b)(6), male. On 09aug2017 additional information received from the customer reporting: it is a micro tool with a small dissecting tip. The doctor and the resident were working under the microscope freeing up tissue/removing disc from the anterior cervical spine at the time tip broke off.
 
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Brand NameRHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
5 sunnen dr
st. louis MO 63143
Manufacturer Contact
anna wehrheim
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6777408
MDR Text Key255157429
Report Number1923569-2017-00049
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL3785-16
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/09/2017 Patient Sequence Number: 1
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