MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BALL NOSE GUIDE WIRE 80CM; INSTRUMENT/TRAUMA

Model Number	N/A
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	11/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner sterile packaging for the device was damaged.Subsequently, another device had to be opened and used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).Visual inspection of the returned product found damage to the outer carton and a hole in the sterile packaging pouch that penetrates both sterile barriers.Sterility has been compromised.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported event can be attributed to transit damage.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: BALL NOSE GUIDE WIRE 80CM
• Common Device Name: INSTRUMENT/TRAUMA
• 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: 13062787
• Report Number: 0001825034-2021-03461
• Device Sequence Number: 11177975
• Product Code: FZX
• UDI-Device Identifier: 00887868027857
• UDI-Public: (01)00887868027857(17)310630(10)508460
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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 Model Number: N/A
• Device Catalogue Number: 281001080
• Device Lot Number: 508460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• 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: 12/01/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown