MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 CORT BONE SCREW 16MM; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi: (b)(4).Report source: (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 by the incoming inspection team, a member found a hole in the package.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.

• Brand Name: 3.5 CORT BONE SCREW 16MM
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10080117
• Report Number: 0001825034-2020-02098
• Device Sequence Number: 3732019
• Product Code: HWC
• UDI-Device Identifier: 00887868009112
• UDI-Public: (01)00887868009112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K905048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 1437716
• Device Lot Number: J6318333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/21/2020
• 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