MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISPOSABLE BONE CEMENT CURETTE; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the packaging containing the curette was opened at the bottom and that the packaging had not been sealed during manufacturing.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Report source: foreign (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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Visual evaluation of the returned product found the tyvek pouch was not sealed during manufacturing.This complaint has been confirmed by evaluation of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history found no additional related issues for the reported product.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event is the packaging operator not following the work instructions provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: DISPOSABLE BONE CEMENT CURETTE
• Common Device Name: HIPS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16618919
• Report Number: 0001822565-2023-00818
• Device Sequence Number: 7211813
• Product Code: HTF
• UDI-Device Identifier: 00889024376625
• UDI-Public: (01)00889024376625(17)261104(10)65326774
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 Model Number: N/A
• Device Catalogue Number: 00504905300
• Device Lot Number: 65326774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown