MAUDE Adverse Event Report: BIOMET ORTHOPEDICS PRELUDE PF THD GUIDE PIN 5PK; FIXATION, PIN

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-03749 / 03750).

Event Description

It was reported that during an initial left knee procedure on (b)(6) 2015, the impactor fractured causing it to jam into the 8w left cut guide and moving the guide.This caused one of the pins to fracture inside of the patient.The fractured piece could not be removed.The surgeon was able to replace the guide and continue the surgery without issue.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that during an initial left knee procedure on (b)(6) 2015, the reamer jammed into the 8w left cut guide causing the guide to move, which in turn broke one of the pins holding it down.The fractured piece of the pin was retained by the patient.The surgeon replaced the guide and continued the surgery.It was also reported that the impactor fractured.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.A product evaluation was conducted on the returned product, the impactor pn:110004172 ln: 979740 and the guide pn:110004121 ln: unknown.Examination of returned devices found no evidence of product non-conformance.Review of the devices confirmed the reported condition.However, a conclusive root cause could not be determined.Product location unknown.

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.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.

• Brand Name: PRELUDE PF THD GUIDE PIN 5PK
• Type of Device: FIXATION, PIN
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5032451
• MDR Text Key: 24133578
• Report Number: 0001825034-2015-03750
• Device Sequence Number: 1
• Product Code: JDW
• 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: other
• Type of Report: Followup,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110004170
• Device Lot Number: DEC 31, 2014
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR