MAUDE Adverse Event Report: CAREFUSION, INC VITAL METZ DISCT SCISSOR CVD BL/BL 7IN; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	MO1601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).On 11apr2022 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Event or Problem Description
Curved vital metz 7-inch mo1601, tip of scissor broke off during surgery and fell into patient's knee.The surgeon was able to retrieve with no harm to patient.On 15apr2022 additional information: what was the procedure that was being performed? right knee acl revision.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? the tip of the scissors broke off into the patient¿s right knee.Surgeon retrieved the broken tip.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no, x-ray was not performed.What was the patient¿s outcome? no harm to the patient.Was the procedure completed as planned? yes, procedure completed w/o any further complications.Can you please send all parts of the instrument for evaluation? incident took place on (b)(6) 2021.The instrument was not saved by staff.Do you have the lot number? no.Do you have photos of the reported issue on the instrument? no.The complaint sample, photos, lot number, or further information are not available.

• Brand Name: VITAL METZ DISCT SCISSOR CVD BL/BL 7IN
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14160844
• Report Number: 1423507-2022-00011
• Device Sequence Number: 20073944
• Product Code: LRW
• UDI-Device Identifier: 10885403058844
• UDI-Public: (01)10885403058844
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2022
• Report Date (Section F): 04/20/2022

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: MO1601
• Device Catalogue Number: MO1601
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/20/2022