MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ACET PUNCH; HIP INSTRUMENTS : REAMERS

Model Number	6020-29-000
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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
Moreland set ¿leaking¿ and producing odor when sterilized.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Additional Manufacturer Narrative
The device malfunction, visual : foreign substance/debris/cleaning/sterilization, will no longer be reported as there has not been a serious injury associated with this failure within the past 2 years.Please consider this the last manufacturer report number submitted against this malfunction.

• Brand Name: ACET PUNCH
• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10464844
• Report Number: 1818910-2020-18971
• Device Sequence Number: 2552860
• Product Code: LRY
• UDI-Device Identifier: 10603295178538
• UDI-Public: 10603295178538
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2020

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: 6020-29-000
• Device Catalogue Number: 602029000
• Device Lot Number: BG0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 08/25/2025
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/09/2020; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown