MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP SRS NEXEL 70MM DST BDY RT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES

Model Number	110029940
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that once the package was opened the packaging was damaged and opened.
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6 visual evaluation of the returned product/provided photos found black staining on the inside of the device pouch.Review with the packaging team identified that the staining is likely the result of friction between the device and the pouch during transit.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMP SRS NEXEL 70MM DST BDY RT
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15929311
• Report Number: 0001825034-2022-02754
• Device Sequence Number: 4347365
• Product Code: JDC
• UDI-Device Identifier: 00880304850415
• UDI-Public: (01)00880304850415(17)260711(10)771600
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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 Expiration Date: 07/11/2026
• Device Model Number: 110029940
• Device Catalogue Number: 110029940
• Device Lot Number: 771600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female