MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SNAPSHOT MINI OPEN FULL KIT; PROSTHESIS, SPORTS MED

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

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 a snapshot mini open kit was opened and the seal on the package was stuck together calling into question its sterility.

Manufacturer Narrative

(b)(4).Upon receipt of the investigation it has been determined that this device did not cause or contribute to the reported event.It was found that the seal area found no other areas of concern.Seal is intact and sterility has not been compromised, in which case there is not previously reported issues.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.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

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: SNAPSHOT MINI OPEN FULL KIT
• Type of Device: PROSTHESIS, SPORTS MED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10240231
• MDR Text Key: 198146587
• Report Number: 0001825034-2020-02643
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00887868251061
• UDI-Public: (01)00887868251061(17)240701
• Combination Product (y/n): N
• PMA/PMN Number: K143037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 110019010
• Device Lot Number: 394880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1