MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPIKE ARM; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: canada.Customer 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 pounded in the spike arm for the guide.Upon removal it was noticed the larger front spike had broken off the spike arm.The surgeon removed the spike arm and noticed the broken spike was still in the patient's tibia.He removed the broken spike and discarded.No piece of the the spike was left in the patient.There was no delay, no patient impact.

Event Description

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

Manufacturer Narrative

Visual examination of the returned product identified signs of repeated use and the long spike has fractured from the device and was not returned.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.The device has a potential field age of over 15 years and exhibit signs of repeated use.The root cause of the reported event is attributed to wear and tear from repeated use over time.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is confirmed 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: SPIKE ARM
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15699765
• MDR Text Key: 303563059
• Report Number: 0001822565-2022-03089
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 00599707300
• Device Lot Number: 60744499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2007
• Is the Device Single Use?: No
• 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 Age: 81 YR
• Patient Sex: Female