MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE INSERTER TIP DO NOT IMPLANT; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that when the surgeon opened the package of the ppk inserter tip, he found that something like lint was seen on the product.Subsequently, he decided not use it and another ppk inserter tip was used to complete the procedure.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Visual inspection of returned packaging and product found the carton and cavities were opened.Evaluation of the product and packaging did not find any foreign debris.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined as the product and packaging were returned opened, and therefore it cannot be determined when or how the foreign debris was introduced.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.

• Brand Name: ARTICULAR SURFACE INSERTER TIP DO NOT IMPLANT
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11506965
• Report Number: 0001822565-2021-00748
• Device Sequence Number: 17130086
• Product Code: LXH
• UDI-Device Identifier: 00880304810211
• UDI-Public: (01)00880304810211(17)250331(10)64655909
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 42529900301
• Device Lot Number: 64655909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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