MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REV REAMERS STER TRAY; KNEE INSTRUMENT : INSTRUMENT CASES

Model Number	2178-64-105
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tray where the reamers for tc3 are laying the rubber part is breaking and the sterile department do not want to use tray for safety reasons.The plastic on the tray is falling apart.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Reviewing the photos provided on the attachments the reported event was confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the device lot number is unknown; therefore, a mre could not be performed.If more information become available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not returned.Reviewing the photos provided on the attachments the reported event was confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot = > the device lot number is unknown; therefore, a mre could not be performed.If more information become available, the record will be re-assessed h10 additional narrative: added: b5.
Event or Problem Description
Hold for bf 11/17.Instead of reported product code 2178-64-105, the franchise received product with the code 2178-64-108.Could you please confirm if received product with the number 2178-64-108 belongs to this complaint and the customer reported originally wrong product code 2178-64-105? or do they have also another complaint? answer:.The tray they showed me was 217864105.I can´t see what kind of tray 217864108 looks like ( i have tried go inventory), do you have a picture on that tray (217864198), so i can see what you mean? if you look at the picture below, they were complaining on the rubberpart where the drills are laying.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual examination of the device confirmed the complaint.The rubber parts of the case have started to chip at the edges.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: REV REAMERS STER TRAY
• Common Device Name: KNEE INSTRUMENT : INSTRUMENT CASES
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13422540
• Report Number: 1818910-2022-02073
• Device Sequence Number: 4854106
• Product Code: FSM
• UDI-Device Identifier: 10603295096566
• UDI-Public: 10603295096566
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2022

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: 2178-64-105
• Device Catalogue Number: 217864105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 03/16/2022; 04/19/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/28/2022; 03/24/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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