MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. MIXING SYSTEM; MIXING SYRINGE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Not Applicable (3189)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

During the procedure, the bsm was being mixed in a mixing syringe by the technician.While mixing, the plunger had broken off of the mixing syringe, and the bsm was unable to be expelled from the syringe.A nurse had to obtain a new syringe and more bsm for the surgery to be completed, which resulted in a delay of 40 minutes.

Event Description

Plunger broke while reassembly refer to (b)(4).

Manufacturer Narrative

The surgery was successful upon mixing the third kit.A retain sample from the same lot was tested and the device performed within specification.Per the ifu, "the use of a surgical instrument for tasks other than those for which they are intended may result in damaged or broken instruments or patient injury.Make sure the product is only used by qualified or trained staff." the most likely root cause is user error/technique.

Event Description

Plunger broke while reassembly.Refer to (b)(4).

• Brand Name: MIXING SYSTEM
• Type of Device: MIXING SYRINGE
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 7386092
• MDR Text Key: 103975115
• Report Number: 3008812173-2018-00011
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04674
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2017
• 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 Outcome(s): Other
• Patient Age: 67 YR