MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GRTBATCH OFF CUP IMP MTL HNDL; HANDLES

Model Number	511172
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the latch broke on offset cup impact.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report was submitted in error.Depuy is not the manufacturer or supplier of this product.Please disregard this report.
Additional Manufacturer Narrative
This report was submitted in error.  depuy is not the manufacturer or supplier of this product. depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: GRTBATCH OFF CUP IMP MTL HNDL
• Common Device Name: HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9636362
• Report Number: 1818910-2020-03149
• Device Sequence Number: 19424753
• Product Code: LXH
• UDI-Device Identifier: 00840096400045
• UDI-Public: 00840096400045
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2020

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: 511172
• Device Catalogue Number: 255000115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 01/12/2021
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/06/2020; 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1