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

Model Number DYNJ904781

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

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 Description

It was reported that two surgical blades broke and a piece fell into the surgical site.

• Brand Name: Medline Industries, Inc.
• Type of Device: SURGICAL BLADE IN TOTAL HIP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, il ; 9311458
• MDR Report Key: 9686568
• MDR Text Key: 190759763
• Report Number: 1423395-2020-00001
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942725342
• UDI-Public: 10889942725342
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention