MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE FEMORAL FINISHING GUIDE RIGHT MEDIAL SIZE 4; INSTRUMENT, KNEE

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign - (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon was unable to push a 127mm thick saw blade through the posterior cutting slot of the finishing guide during a procedure.Upon inspection of the device, it was confirmed that the cutting slot was tapered at the outer edge, preventing insertion of the saw blade.The finishing guide was new and had never previously been used.Attempts have been made, but no additional information is available at this time.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned cut guide had significant gouging as well as burrs at the anterior drill hole, however, no significant damage was seen at the posterior cut slot.Dimensional analysis of the posterior cut slot determined that the slot is slightly tapered and would not accept a pin gage of 0.052 mm, which is smaller than the lower dimensional bound.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: PERSONA PARTIAL KNEE FEMORAL FINISHING GUIDE RIGHT MEDIAL SIZE 4
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7665315
• MDR Text Key: 113284727
• Report Number: 0001825034-2018-04455
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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: 42578100402
• Device Lot Number: 63925254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1