MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*INTRODUCER SLEEVE BODY16; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	534316
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 (b)(6) 2018 via tha.After the trial sleeve was inserted to the patient¿s femur, it was reported that the surgeon felt difficulty to remove the trial sleeve because the connection part of the sleeve introducer and introducer handle were detached when the surgeon hit the connection part to release while the trial sleeve was removed.The surgeon attempted to remove the trial sleeve several times, and finally it was removed by using elevators.The same condition was occurred (difficulty to release) when the sleeve was implanted to patient¿s femur.There was less than 30min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Examination of the returned instrument cannot confirm the complaint.Depuy 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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7777444
• Report Number: 1818910-2018-66469
• Device Sequence Number: 16570501
• Product Code: HWR
• UDI-Device Identifier: 10603295171928
• UDI-Public: 10603295171928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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 Catalogue Number: 534316
• Device Lot Number: AH0606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1