MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4 PEG MOD GLEN SZ 3; PROSTHESIS, SHOULDER

Catalog Number SAGL2043

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that during procedure the inner package was opened and a hair was found next to the implant.Additional unit was available to complete the procedure.There were no issues no delay.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: (b)(4).Visual examination of the returned product identified a hair-like fiber stuck to the inner retainer.The product was returned completely opened with no tyvek lid attached to the inner sterile cavity.Not all the packaging materials were returned.Device history record review identified no deviations or anomalies related to the reported issue during manufacturing.The likely condition of the part when it left zimmer biomet control is considered conforming based on the dhr review but it cannot be confirmed because the product was returned completely opened.A definitive root cause cannot be determined.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: 4 PEG MOD GLEN SZ 3
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10470921
• MDR Text Key: 204906651
• Report Number: 0001822565-2020-03030
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K191814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAGL2043
• Device Lot Number: 64713484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1