MAUDE Adverse Event Report: CAREFUSION, INC RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN; INSTRUMENT, MICROSURGICAL

Model Number	NL3785-009
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported that the instrument broke during a case.It was reported that no piece of the device fell off in the patient and no medical intervention was required.The procedure was completed.
Additional Manufacturer Narrative
(b)(4) supplemental emdr.One nl3785-009 rhoton hook was reported and returned as the sample for evaluations.Etchings were noted to be clear and legible: the lot code was displayed as d20, indicating that this device was manufactured in april 2020.Upon initial visual inspections, the sample displayed light signs of usage, and light wear on the surfaces.Overall, the sample appeared to be like new, yet lightly used.The surfaces were noted to be normal and still with the factory applied finish.It was further noted that the sample was returned whole yet missing the broken off working end tip.The broken tip was not located in the return packaging and was likely noted to be with the user or missing.Based on the provided description and visual confirmation, the broken rhoton hook tip failure mode was confirmed on the working end of the sample.Upon closer examination of the broken end, it was noted that it may have snapped off due to a sudden or jarring impact.Rather than a prolonged fatigued failure, this type of failure would display goose-necking/tapering (ductile fracture).The broken end displayed light discoloration, possibly from raw metal exposure (oxidation).The break occurred at/near the bend area 0.010 to 0.015 inches below the bend.This break appeared to be the most likely area of failure due to possible pressing forces applied to the tip causing the snapping fracture.The sample was determined to be non-repairable and non-functional.Furthermore, the sample was measured at the width dimension right at the area of break to verify dimension width conformance per print.Visually, the sample appeared to be within conformance.It was measured with a caliper at the width dimension.The measurements were noted as 0.018 to 0.022 inches which is within conformance of the defined thickness specification of neck area near the bend.Further dimensional measurement confirmations of the working end tip could not be concluded due to missing hook tip.Based on the gathered observations, the reported failure most likely occurred during the user handling or mechanical overstress/excessive forces were applied.H3 other text : evaluation has been performed.
Event or Problem Description
It was reported that the instrument broke during a case.It was reported that no piece of the device fell off in the patient and no medical intervention was required.The procedure was completed.

• Brand Name: RHOTON HOOK ANG 90DEG SEMI-SHARP 7-1/2IN
• Common Device Name: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 11240135
• Report Number: 1423507-2021-00001
• Device Sequence Number: 20082975
• Product Code: GZX
• UDI-Device Identifier: 10885403187124
• UDI-Public: (01)10885403187124
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 04/09/2021

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: NL3785-009
• Device Catalogue Number: NL3785-009
• Device Lot Number: G20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1