MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X20 ST; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Will not be returned.

Event Description

It was reported when the package opened and the plastic removed from the box, that the plastic sterile packing was not completely sealed.This was noted by the scout nurse.The implant was not used and another box was opened.

Manufacturer Narrative

Reported event was confirmed based on a previous similar complaint for the same item and lot.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.This event was farther investigated through the capa process.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

No further event information available at the time of this report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X20 ST
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11154891
• MDR Text Key: 226300207
• Report Number: 0001825034-2021-00061
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304677142
• UDI-Public: (01)00880304677142(17)300527(10)652670
• Combination Product (y/n): N
• PMA/PMN Number: K132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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: 180551
• Device Lot Number: 652670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1