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

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, SPORTS MED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10240231
• Report Number: 0001825034-2020-02643
• Device Sequence Number: 3574263
• Product Code: JDR
• UDI-Device Identifier: 00887868251061
• UDI-Public: (01)00887868251061(17)240701
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• 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
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1