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

Catalog Number	DYNJ904781
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a total hip procedure the gauze frayed, shedding lint into the surgical site.The surgeon was required to remove the linted material from the surgical site via an unknown method.The gauze was reportedly inspected prior to the procedure.Fraying occurred on the side of the gauze.There was no medical care required after the procedure was completed.There was no impact to the patient or the procedure being performed.General anesthesia was used however there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No other information has been provided.No sample was returned to the manufacturer for evaluation.Due to the reported event and the need for medical intervention to retrieve the linted material , 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 the gauze frayed, shedding lint into the surgical site.

• Common Device Name: TOTAL HIP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7327888
• Report Number: 1423395-2018-00008
• Device Sequence Number: 1075488
• Product Code: OJH
• UDI-Device Identifier: 10889942725342
• UDI-Public: 10889942725342
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/09/2018

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: No Information
• Device Catalogue Number: DYNJ904781
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/09/2018
• 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