MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 18IN. (46CM) DISPOSABLE CUFF W/PLC - SP, SB; TOURNIQUET, PNEUMATIC

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during incoming inspection, there was foreign substance found in package.There was no patient involvement or impact.Due diligence information complete.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6).G2 foreign: japan.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual inspection confirmed there were several pieces of large debris sealed inside the package of 2 cuffs.Debris exceeds acceptable specifications per packaging materials inspection zpc 8.400.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to the manufacturing process.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
No additional event information available.

• Brand Name: 18IN. (46CM) DISPOSABLE CUFF W/PLC - SP, 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: 19125403
• Report Number: 0001526350-2024-00460
• Device Sequence Number: 7760078
• Product Code: KCY
• UDI-Device Identifier: 00889024382725
• UDI-Public: (01)00889024382725(17)261101(10)73686687
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 09/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 60707510300
• Device Lot Number: 73686687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: Prefer Not To Disclose