MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline Industries, Inc.; SURGICAL BLADE IN TOTAL HIP

Model Number	DYNJ904781
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unspecified procedure, two surgical blades broke.One (1) broken surgical blade piece fell into the surgical site.According to the reporting facility, there was no adverse patient impact or harm related to the incident.Despite multiple good faith attempt the reporting facility was unable to or unwilling to provide additional patient, product, or procedural information.The two surgical blades were returned for evaluation.The two surgical blades were found to be fractured at similar locations on the connector with all fractures noted to be at the posterior of the blades.The reported surgical blade issue was confirmed, however, a root cause was unable to be determined.Due to the reported incident, and in an abundance of caution, 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 two surgical blades broke and a piece fell into the surgical site.

• Brand Name: Medline Industries, Inc.
• Common Device Name: SURGICAL BLADE IN TOTAL HIP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9686568
• Report Number: 1423395-2020-00001
• Device Sequence Number: 10926107
• Product Code: OJH
• UDI-Device Identifier: 10889942725342
• UDI-Public: 10889942725342
• Combination Product (Y/N): N
• 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): 02/10/2020

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: DYNJ904781
• Device Catalogue Number: DYNJ904781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/10/2020
• 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: Other; Required Intervention