MAUDE Adverse Event Report: CAREFUSION, INC CRABTREE DISSECT JIMMY LG TIP BLADE 2MM; HOOK, MICROSURGICAL EAR

Model Number	AU15190
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial emdr: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.If a sample does become available for investigation a supplemental emdr will be submitted with the investigation results.
Event or Problem Description
Tip of the device broke off during use in a tympanoplasty and mastoidectomy.It fell into the patient's ear and was cleared out using suction.There was no adverse effect to the patient and procedure was completed successfully with no delay.
Additional Manufacturer Narrative
(b)(4) supplemental emdr.A au15190 crabtree dissect jimmy lg tip blade 2mm device was returned for manufacturing evaluation.The sample was returned for evaluation with lot code j20 and the normal authentic v.Mueller etchings in the normally etched location on the handle end.The lot code indicated a manufacture date of october 2020.Upon initial inspections the sample was displayed in normal conforming state, no broken parts, no damages, and no heavy wear and tear was observed.Overall, the sample surface's displayed light wear at the working ends, slight discoloration, and some scuffing/scratching.Based off the visual inspection the reported failure mode was confirmed at the working end, the very tip of the sample had broken off and was not returned or noted anywhere in sample packaging.Upon magnified inspections, the break area was noted to be discolored and broken approximately at the right-angle bend of the tip.The broken tip was not available hence it was estimated that approximately 0.080 inch of the tip had broken off and went missing.The break was characterized as a possible ductile type break upon possible impact.For further investigations the sample was measured per product specifications at 4 different points.Dimensions 1 and 4 were noted to be within conformance but, dimensions 2 and 3 could not be measured due to the missing broken tip.Dimensions 1 and 4 were measured on the thicker side of the product specifications.The sample was also tested for hardness and found to be within conformance.The hardness was measured at 50 ¿ 51 hrc, which was within conformance for this device.Additionally, the shaft was noted to be malleable as normally manufactured.It should be noted that this and similar products are manufactured, marketed, and sold as malleable at the shaft.No bending of the shaft was observed and no further damages, cracks, or signs of breaking or weakening were found.The sample was determined to be normally manufactured and conforming before the failure mode occurred.The observations made on the broken area indicate that possible excessive forces were applied at the tip causing it to break but the specific scenario of how the break occurred are not known.H3 other text: n/a.
Event or Problem Description
Tip of the device broke off during use in a tympanoplasty and mastoidectomy.It fell into the patient's ear and was cleared out using suction.There was no adverse effect to the patient and procedure was completed successfully with no delay.

• Brand Name: CRABTREE DISSECT JIMMY LG TIP BLADE 2MM
• Common Device Name: HOOK, MICROSURGICAL EAR
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 11761517
• Report Number: 1423507-2021-00029
• Device Sequence Number: 14172749
• Product Code: JYL
• UDI-Device Identifier: 10885403011580
• UDI-Public: (01)10885403011580
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/04/2021

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: AU15190
• Device Catalogue Number: AU15190
• Device Lot Number: J20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other