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

Catalog Number	530300
Medical Device Problem Codes	Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
After receipt of a loaner kit the cssd is complaining two instruments not to be possible to disassemble for re-processing.Re-processing of instruments is unclear/difficult.No patient involvement, no surgery delay.
Additional Manufacturer Narrative
Product complaint (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned.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, will be filed as appropriate.

• Common Device Name: HIP INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7613559
• Report Number: 1818910-2018-62569
• Device Sequence Number: 16582959
• Product Code: HWE
• UDI-Device Identifier: 10603295171522
• UDI-Public: 10603295171522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2018

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: 530300
• Device Lot Number: SO2019476
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 01/10/2019
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 12/06/2018; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1