MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STAGRAFT DBM PUTTY 10CC; BONE MATRIX IMPLANT, HUMAN-DERIVED

Catalog Number	92-2004
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: stagraft dbm putty 10cc cat# 92-2004 lot# 843700, stagraft dbm putty 10cc cat# 92-2004 lot# 381840.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00757, 0001825034 - 2021 - 00759.
Event or Problem Description
It was reported that a facility discovered three packages with holes in the interior sterile wrap.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 visual evaluation of the returned packaging found all outer foil packs were returned opened.Lot 381840 quantity of 1 had a hole in the inner foil pack.For all product, since the packaging was returned opened, the sterility or breach thereof cannot be determined.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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: STAGRAFT DBM PUTTY 10CC
• Common Device Name: BONE MATRIX IMPLANT, HUMAN-DERIVED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11484947
• Report Number: 0001825034-2021-00758
• Device Sequence Number: 3280909
• Product Code: MQV
• UDI-Device Identifier: 00880304684867
• UDI-Public: (01)00880304684867(11)200114(10)381840
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K082793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: 92-2004
• Device Lot Number: 381840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1