MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 30IN (76CM) DISPOSABLE CUFF W/PLC - DP, SB; TOURNIQUET, PNEUMATIC

Catalog Number	60707010500
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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 g2: japan.
Event or Problem Description
It was reported that during preparation for the surgery, foreign substances were found inside of the unopened sterile package.There was no patient involvement.Due diligence is complete and no additional information is available.There was no adverse event associated with this malfunction.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4) following sections were updated or corrected: b4, b5, d2, d4, d9, e1, e2, e3, g1, g2, g3, g6, h1, h2, h3, h4, h6 and h11.6 pieces of loose particulate measuring between.08mm and.60mm squared -- debris is not within specifications.Packaging is nonconforming.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 was no additional information associated with this malfunction.

• Brand Name: 30IN (76CM) DISPOSABLE CUFF W/PLC - DP, SB
• 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: 20651936
• Report Number: 0001526350-2024-01390
• Device Sequence Number: 6641078
• Product Code: KCY
• UDI-Device Identifier: 00889024377127
• UDI-Public: (01)00889024377127(17)271026(10)65022466
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 60707010500
• Device Lot Number: 65022466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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