MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 18IN. (46CM) DISPOSABLE CUFF W/PLC - DP, 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	02/02/2024
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.
Event or Problem Description
It was reported that the unit had loose particles in packaging.There is no information provided regarding the timing of the event or if there was any patient involvement/harm that may have occurred.Due diligence is in progress, no further information is available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet 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 the loose particles in packaging was found outside of surgery.There was no patient involvement.Due diligence is complete, no further information is available.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided as packaging was conforming and met specification.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided as packaging was conforming and met specification.

• Brand Name: 18IN. (46CM) 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: 18876385
• Report Number: 0001526350-2024-00315
• Device Sequence Number: 7920087
• Product Code: KCY
• UDI-Device Identifier: 00889024382459
• UDI-Public: (01)00889024382459(17)260919(10)72932440
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 09/19/2026
• Device Model Number: N/A
• Device Catalogue Number: 60707010300
• Device Lot Number: 72932440
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 10/29/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/14/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• 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
• Patient Sex: Prefer Not To Disclose