MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 33 DPSB DISP PLC CUFF & SLEEVE; TOURNIQUET, PNEUMATIC

Catalog Number	60707015600
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that on an unknown time, on an unknown date, the device had a debris inside the sealed sterile package.It is unknown if there was no patient injury, or delay.Due diligence is in progress and there is no additional information available.
Event or Problem Description
It was reported that during the assembly of trays, the device had a debris inside the sealed sterile package.There was no patient harm/injury or surgical delay as there was no patient involvement.Due diligence is completed and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b3, b4, b5, g3, g6, h1, h2, h6, h10 and h11.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any action taken by the manufacturer.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: a1, b4, b5, d4, g1, g3, g6, h1, h2, h3, h4, h6 and h11.The products were not returned for evaluation.Visual examination of the provided pictures found there were 3 particles within the device packages.The size of the particles could not be determined.Additionally, it could not be confirmed if the particles were foreign or within the sterile barrier.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There is no additional information available regarding the event.

• Brand Name: 33 DPSB DISP PLC CUFF & SLEEVE
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22177160
• Report Number: 0001526350-2025-00737
• Device Sequence Number: 7957764
• Product Code: KCY
• UDI-Device Identifier: 00889024377202
• UDI-Public: (01)00889024377202(17)270821(10)78710348
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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 Catalogue Number: 60707015600
• Device Lot Number: 78710348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 11/13/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/17/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown