MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ZIMMER HUDSON TO HUDSON ADAPTR; GENERAL/MISC INSTRUMENT

Catalog Number	244300000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/18/2017
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
It was reported that after reaming with the summit tapered reamers, the reamer handles would disconnect from the hudson adaptor and would keep pulling the reamer out of the femoral canal.Upon inspection during the procedure, the scrub nurse found that the adaptor looked to be bent at the point of connection.After terminally sterilized by mdr, they couldn't find a major bend or any damage, but the adaptor did not seem to hold the connection well.Considering that the reamer handles were not damaged whatsoever, they decided that the problem must be with the hudson adaptor and that it should be replaced in order to avoid any such problem again.
Additional Manufacturer Narrative
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.

• Brand Name: ZIMMER HUDSON TO HUDSON ADAPTR
• Common Device Name: GENERAL/MISC INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7029517
• Report Number: 1818910-2017-28932
• Device Sequence Number: 19118767
• Product Code: HWE
• UDI-Device Identifier: 10603295124597
• UDI-Public: 10603295124597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 244300000
• Device Lot Number: BL1202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1