MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIGH CAPACITY NARROW INTRAMEDULLARY TIP; LAVAGE HANDPIECE TIP

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01215, 0001526350-2023-01216.
Event or Problem Description
It was reported that during inspection at arrival, the product was found to be nonconforming.The product had a hair like debris in the sterile package.There was no patient involvement.Due diligence is complete, no further information is available.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported since the packaging was found to be within the acceptable criteria.This medwatch is being voided.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported as the packaging was found to be within the acceptable criteria.This medwatch is being voided.

• Brand Name: HIGH CAPACITY NARROW INTRAMEDULLARY TIP
• Common Device Name: LAVAGE HANDPIECE TIP
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17820294
• Report Number: 0001526350-2023-01214
• Device Sequence Number: 6161632
• Product Code: FQH
• UDI-Device Identifier: 00889024379909
• UDI-Public: (01)00889024379909(17)260523(10)66038886
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 00515018200
• Device Lot Number: 66038886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: Prefer Not To Disclose