MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPONENT KIT; SURGICAL IRRIGATION/ASPIRATION PUMP, SINGLE-USE

Model Number N/A

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that during surgery batteries in system were corroded and device did not work.There was a patient involved but unknown impact, harm, or delay.Due diligence information is complete.No additional information available at this time.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6).G2 foreign: canada.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that at the beginning of surgery the batteries in system were corroded, and the device did not work.The device would not turn on.No impact, harm, or delay were reported.Due diligence information is complete.No additional information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 not 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.

• Brand Name: COMPONENT KIT
• Type of Device: SURGICAL IRRIGATION/ASPIRATION PUMP, SINGLE-USE
• 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: 18277957
• MDR Text Key: 329929848
• Report Number: 0001526350-2023-01617
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515042000
• Device Lot Number: 70849494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose