MAUDE Adverse Event Report: ZIMMER INC FUZION FEMORAL PLATE TENSIONER; HWT

Catalog Number 42509703100

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that during surgery, the fuzion instrument cut the medial collateral ligament.The surgeon had to make a suture of the medial ligament and do a reconstruction of the mcl with semitendinosus graft to achieve stability.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Visual inspection of the returned paddle identified some scuff marks indicative of use.Measured dimensions were conforming to print specifications.Review of the device history records and receiving inspection report identified no deviations or anomalies.This device is used for treatment.A product history search identified no other complaints for this part and lot combination.Primary operative notes state that the patient's mcl was severed by the sharp edges of the grip feature during insertion of the paddle.Follow up information indicates that the surgeon was using the paddle with the tensor assembly.The mcl was reconstructed using a semitendinosus graft and the surgery was completed using the persona measured resection instrumentation.The knee was determined to be stable upon completion of the surgery.Further investigation identified that the event leading to this harm was not specifically addressed in the fuzion beta instruments risk analysis.Therefore the risk analysis was updated to address the specific risk that the edges of the paddles damage soft tissue.Per the persona fuzion design validation report, the grip feature of the paddle was considered to be clinically acceptable.The investigation identified that this is an isolated event and not related to a design or manufacturing issue.

• Brand Name: FUZION FEMORAL PLATE TENSIONER
• Type of Device: HWT
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5278492
• MDR Text Key: 33053677
• Report Number: 1822565-2015-02618
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 42509703100
• Device Lot Number: 63037647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 50