MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CRV MINI KAMVAC SUCTION TUBE; SURGICAL ACCESSORIES : ENVIRONMENTAL PROTECTION

Model Number	5300-20-500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that while completing a hip arthroplasty, surgeon noticed kam vac suction tip had broken while in use.Suction tip removed from sterile set-up and replaced by new suction.Surgeon searched the field for broken pieces and irrigated the wound with normal saline.Since xray was in use for procedure, xrays taken of field.Surgeon stated he could not find any pieces of the suction tip while in the field.Broken suction tip and packaging retrieved and given to patient care coordinator.Incident report completed during time of surgery.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received stated the following: what type of procedure was being performed? a hip arthroplasty.Were there any fragments that were broken off inside the patient? surgeon noticed, kam vac suction tip had broken while in use.If yes, were the fragments retrieved? broken suction tip and packaging retrieved.And given to patient care coordinator.

• Brand Name: CRV MINI KAMVAC SUCTION TUBE
• Common Device Name: SURGICAL ACCESSORIES : ENVIRONMENTAL PROTECTION
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11574770
• Report Number: 1818910-2021-06224
• Device Sequence Number: 14488023
• Product Code: JOL
• UDI-Device Identifier: 10603295171515
• UDI-Public: 10603295171515
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 5300-20-500
• Device Catalogue Number: 530020500
• Device Lot Number: 69981205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1