MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUSHING RONGEUR STRAIGHT 2 MM X 10 MM; TRAUMA INSTRUMENTATION

Catalog Number 00336000000

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not received.

Event Description

It was reported that the patient underwent lumbar discectomy and while removing the loose disc fragments, the instrument broke.Surgery was prolonged by an hour.The patient retained broken rongeur jaw piece.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: CUSHING RONGEUR STRAIGHT 2 MM X 10 MM
• Type of Device: TRAUMA INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8588604
• MDR Text Key: 144386490
• Report Number: 0001822565-2019-01899
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00336000000
• Device Lot Number: 60858642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 105