MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	47249532011
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item# 47249532011; lot# 66216691.Item# 47249532011; lot# 66216691.Item# 47249532011; lot# 66216691.Item# 47249530009; lot# 66546286.G2: foreign - event occurred in costa rica.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 that during receiving inspection, it was discovered that the inner and outer packaging of the tibial nail was noted to be damaged.No patient involvement occurred.Attempts have been made and no further information has been provided.
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.Visual evaluation of the provided photos and returned product found damage to the outer carton and inner sterile packaging.Sterility has been breached.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet control is considered conforming to specification.The root cause of the reported event can be attributed to transit damage.This complaint was confirmed by evaluation of the provided photos and returned product.If any further information 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: ZIMMER NATURAL NAIL SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 20652050
• Report Number: 0001822565-2024-03524
• Device Sequence Number: 6772893
• Product Code: HSB
• UDI-Device Identifier: 00889024097513
• UDI-Public: (01)00889024097513(17)340504(10)66216691
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K082770
• 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): 03/17/2025

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 Catalogue Number: 47249532011
• Device Lot Number: 66216691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Patient Sex: Prefer Not To Disclose