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

Catalog Number	CDS920027T
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during a total hip procedure, a piece of hair was found on a lap sponge.

• Common Device Name: TOTAL HIP CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7439777
• Report Number: 1423395-2018-00020
• Device Sequence Number: 16573646
• Product Code: OJH
• UDI-Device Identifier: 10889942749409
• UDI-Public: 10889942749409
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: CDS920027T
• Device Lot Number: 18AB9270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/18/2018
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 80