MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ZIMMER HUDSON TO HUDSON ADAPTR; MISCELLANEOUS JOINT INSTRUMENTS : ADAPTORS

Catalog Number	244300000
Medical Device Problem Codes	Crack (1135); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
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 surgeon was reaming the femur during a total hip and the hudson adaptor bent and produced a small crack.They opened another one to continue.Instrument needs to be replaced.Nothing fell into patient.No patient consequence and no surgical delay.One impacted, one needing replacement.
Additional Manufacturer Narrative
Pc-(b)(4).Examination of the returned device confirmed then reported cracking.Depuy considers the investigation closed.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: MISCELLANEOUS JOINT INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7805134
• Report Number: 1818910-2018-67392
• Device Sequence Number: 1351058
• Product Code: HWE
• UDI-Device Identifier: 10603295124597
• UDI-Public: 10603295124597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 244300000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1