MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X30MM LOW PRO CORT SCR STE; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report spouce foreign: (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 Description

It was reported by the distributorship that the products were found to be nonconforming.Our incoming inspection team member found debris in the sterile package.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual inspection of the returned product found no damages to the outer box and the inner contents.Inspection found a small circular piece of debris within the part sleeve.The debris is from the hole cutout of the part sleeve.Device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.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: 3.5X30MM LOW PRO CORT SCR STE
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12083440
• MDR Text Key: 258966695
• Report Number: 0001825034-2021-01902
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868362478
• UDI-Public: (01)00887868362478(17)300610(10)798640
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 851235030
• Device Lot Number: 798640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1