MAUDE Adverse Event Report: CAREFUSION, INC SUNDT BALL TIP DISSECTOR OVER LENGTH 7IN; INSTRUMENT, SURGICAL, NON-POWERED

Model Number	NL1098
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.
Event or Problem Description
The ball tip broke off at the end during spinal surgery.The piece was extracted with forceps and validated through fluoroscopy.No harm was reported to the patient and the surgery was completed as planned.
Event or Problem Description
The ball tip broke off at the end during spinal surgery.The piece was extracted with forceps and validated through fluoroscopy.No harm was reported to the patient and the surgery was completed as planned.
Additional Manufacturer Narrative
(b)(4) supplemental emdr.Two nl1098 sundt ball tip dissectors were returned for product evaluations.Etchings on the samples were noted to be clear and legible: the lot code on both of the samples was displayed as a20, indicating that these devices were manufactured in jan 2020.Upon initial visual inspections, both of the a20 samples displayed light signs of usage, and light wear on the surfaces.Overall, the samples appeared to be like new, yet lightly used, and the surfaces were noted to be normal with the factory applied finish.It was further noted that the samples were returned whole yet missing the broken off working end tips.The broken tips were not located in the return packaging and were declared with the customer or missing.Based on the provided description and visual confirmation, the broken ball-tips failure mode was confirmed on the working ends of both samples.Upon closer examination, the broken ends appeared to have the tips snapped off due to a sudden or jarring impact.Rather than a prolonged fatigued failure where the area of break would display goose-necking/tapering (ductile fracture).The broken ends displayed slight discoloration, possibly from raw metal exposure oxidation.The break for both samples occurred at/near the bend area 0.010 inches below the bend for one a20 sample and the other a20 sample¿s break was 0.015 inches away from the bend.This break was likely caused by pressing forces applied to the tip causing the snapping fractures.Both samples were determined to be non-repairable and non-functional.Furthermore, both samples were measured for width dimensions right at the area of break to verify dimension width conformance per print using a caliper.Visually, the samples appeared to be within conformance and the measurements were noted as 0.022 inches for one a20 sample and 0.023 in for the other.Both of these measurements are within conformance of the defined thickness specification of neck area near the bend.It should also be noted that the width thickness were on the thicker side of the conforming high tolerance.Based on the gathered observations the failure mode most likely occurred during the user handling or a mechanical overstress/excessive force being applied.H3: evaluation has been performed.

• Brand Name: SUNDT BALL TIP DISSECTOR OVER LENGTH 7IN
• Common Device Name: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 10868360
• Report Number: 1423507-2020-00057
• Device Sequence Number: 2489752
• Product Code: HAO
• UDI-Device Identifier: 10885403070785
• UDI-Public: (01)10885403070785
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NL1098
• Device Catalogue Number: NL1098
• Device Lot Number: A20
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1