MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP NLK SCR 3.5HEX 4.75X35 ST; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) visual inspection found the shrink wrap to be cut open, exposing the labeled end of the packaging.Light creasing is present near the open end where the product was removed.The pouch seal is open on one end with a portion of the material being torn away from the pouch.Sterility has been compromised.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Evaluation of the device found the packaging was likely opened by the previous customer and therefore; the root caused 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.

Event Description

It was reported that a device was returned with packaging damage and the sterility barrier potentially compromised.There is no additional information.

• Brand Name: COMP NLK SCR 3.5HEX 4.75X35 ST
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15163111
• MDR Text Key: 302776946
• Report Number: 0001825034-2022-01790
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304677289
• UDI-Public: (01)00880304677289(17)320228(10)728860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180561
• Device Lot Number: 728860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1