MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. UNKNOWN WOUND DEBRIDEMENT DEVICE; LAVAGE, JET

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2008

Event Type  Injury  

Event Description

It was reported that two pieces of pulsavac broke off and were left in the patient's knee during a procedure in 2008.The patient underwent a revision surgery with the same surgeon in 2014, then there was a second revision surgery in 2019, followed by a wash out procedure, a manipulation under anesthesia, and an exploratory surgery, all performed by a different surgeon.The two pieces of plastic were discovered by the second surgeon during the exploratory surgery in 2020.No additional adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.

Event Description

No additional information is available.

Manufacturer Narrative

This incident has been recorded under: (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The event cannot be 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.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.

Event Description

No additional event information.

• Brand Name: UNKNOWN WOUND DEBRIDEMENT DEVICE
• Type of Device: LAVAGE, JET
• 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: 16268660
• MDR Text Key: 308439375
• Report Number: 0001526350-2023-00107
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK PULSAVAC
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male