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

Model Number NL3785-16

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

The customer reported, the tip broke off during a case.No patient was adversely affected by this failure, however a patient case alert/incident report was generated.On (b)(6) 2017 the customer reported, the patient was a (b)(6) year old male, there was no patient injury or intervention, unknown if the device broke in the body field, the patient did require an additional x-ray, the device was removed from use and replaced with another, the spine surgery was completed as planned.Although asked, no additional information was provided.

Manufacturer Narrative

(b)(6).Device manufacture date: may 2004.One (1) rhoton ball dissector 3mm 90deg 7-1/2in was reported and returned as the complaint sample.The etching was noted on the shaft body as legible, the lot code was verified as e04 (may 2004); sample was possibly in use for 13 years.The sample displayed some signs of usage and cleaning; overall the sample¿s finish was like new.The sample was sent in as one single part with no other pieces or parts sent along.The sample¿s appearance matched the print drawing: it was approximately 7.5 inches long and approximately 0.14 inches width, at its thickest part (knurled handle).Slight discoloration spots were noted on random areas on the knurled handle and minor fine scratches were noted on the smooth shaft part.The broken failure mode was confirmed on the working-end of the tip, the small right angle dissector tip end was broken off the sample and missing.The area of failure was further examined under 3 times magnification the break point appeared to be dark and discolored possibly due to oxidation of the exposed raw material of the broken surface, the break had characteristics of possible brittle fracture as a result of tensile stress on the neck of the break.The break area had a slight bend on it indicating it occurred at the 90 degree manufactured bend of the tip.The error most likely occurred during use, as the most stress is present at the 90 degree bend of the tip.For further verifications the very end of the broken tip was measured for width of neck at bend.Print indicates a width thickness of 0.020 inches +/-.003, it was measured at 0.022, which is in conformance at the thicker side of the print specification.It is not known what the shape, condition and dimensions of the broken off tip are, however based on the investigation thus far the sample appears to be manufactured correctly.The sample did not display any other signs of excessive forces or residual bending of the shaft and/or handle.No cracks, breaking, corrosion and/or signs of repair modifications were noted.The sample was determined to be completely non-functional and unable to be repaired.Device history records for nl3785-16 from lot code e04 were reviewed: all work instructions were completed accordingly.Qa inspections were performed.No issues related to the failure mode were identified.Conclusion(s): based on returned samples analysis: most probable root cause was identified as possible excessive forces applied to the tip during usage that may have been beyond the strength/hardness capabilities of the sample.It should be noted that the sample is over 13 years old; the frequency of usage of the sample is unknown.It is also possible that the sample¿s working end may have weakened due to stresses applied over the 13 years it has been in use.The sample was measured and manufacturing processes were reviewed to indicate no issues.Bd quality will continue to monitor and track issue similar to this complaint for trending purposes.

• Brand Name: RHOTON BALL DISSECTOR 3MM 90DEG 7-1/2IN
• Type of Device: RONGEUR, 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 Key: 6863128
• MDR Text Key: 87307272
• Report Number: 1923569-2017-00053
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3785-16
• Device Lot Number: E04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR