MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*EXTENSION REAMER HUDSON; HIP INSTRUMENTS : ADAPTORS

Model Number	53-0300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument partially confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed on an unknown date via tha.It was reported that the revision surgery was performed on (b)(6) 2020.The reason of the revision surgery is the cup sinking to the acetabular.The fixation of the stem was good, but it was removed because it interrupted to remove the cup.During the surgery, when the surgeon set a cone reamer to the extension reamer hudson, attached them to a power tool and checked the action, the rotation was eccentric.The surgeon used the devices to drill the femoral medullary cavity, the surgeon had a risk to break the femur due to the device¿s eccentric rotation.He proceeded with the procedure carefully and as a result the duration of the surgery was extended about less than 30 minutes.The feared event did not happen.No further information is available.

• Common Device Name: HIP INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11026941
• Report Number: 1818910-2020-27132
• Device Sequence Number: 777920
• Product Code: HWE
• UDI-Device Identifier: 10603295171522
• UDI-Public: 10603295171522
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 53-0300
• Device Catalogue Number: 530300
• Device Lot Number: AB0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1