MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOTAL HIP CDS

Catalog Number CDS920027T

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during a total hip procedure, a piece of hair was found on a lap sponge.The back table of supplies and instruments was reportedly torn down and a new set-up of supplies and instruments was obtained.The procedure was completed without further incident.The procedure lasted thirty (30) minutes longer than expected and the patient was required to receive an unidentified antibiotic.No adverse effect to the patient's status or stability was reported.A sample was not available to be returned to the manufacturer for evaluation.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during a total hip procedure, a piece of hair was found on a lap sponge.

• Type of Device: TOTAL HIP CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7439777
• MDR Text Key: 106143618
• Report Number: 1423395-2018-00020
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942749409
• UDI-Public: 10889942749409
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CDS920027T
• Device Lot Number: 18AB9270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 80