MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENT RESTRICTOR WITH NOZZLE 1 - 16 MM DIAMETER 1 - 25 MM DIAMETER; INSTRUMENT, EXTREMITIES

Catalog Number	32810503800
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
It was reported approximately three (3) weeks ago, during the inspection of the loaner kit in the (b)(6) warehouse, the packaging was detected to be opened and bent.The product was not in circulation yet as it was located in quarantine after detection in the inspection.Not patient involved.No surgery occurred.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2.Event is to remain as an open complaint will continue to be investigated.Please disregard the previous voidance report submitted.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.Damage was to the outer packaging and not the sterile packaging; therefore, the sterility was not compromised.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2 upon reassessment of the reported event, it was determined to be not reportable.Reported event does not allege a product or packaging failure.Reported description and review of feedback provided indicate product was opened during surgery and returned to the loaner kit warehouse opened.The initial report was forwarded in error and should be voided.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: CEMENT RESTRICTOR WITH NOZZLE 1 - 16 MM DIAMETER 1 - 25 MM DIAMETER
• Common Device Name: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12312814
• Report Number: 0001822565-2021-02248
• Device Sequence Number: 17095535
• Product Code: JDC
• UDI-Device Identifier: 00889024274082
• UDI-Public: (01)00889024274082(17)250928(10)64896635
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K040389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/21/2021

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: 09/28/2025
• Device Catalogue Number: 32810503800
• Device Lot Number: 64896635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 11/18/2021; 12/16/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/26/2021; 11/23/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose