MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BURR INSTRUMENT; INSTRUMENT, SURGICAL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 04/12/2017

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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional concomitant medical products: part # 32810504301, interchangeable ulnar assembly, lot # 61830050; part # 00504903501, compact vacuum cement mixing system, lot # 61949805.

Event Description

It was reported that during the patient's first revision of the l elbow, the surgeon found two perforations of the humerus after using a long-tipped burr to remove cement from the humeral canal.Allografts were placed over the holes and secured with an 18 gauge cable.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of radiographs.Review of x-rays noted fractures, likely the hole described, involving the medial epicondyle and supracondylar cortex.Device history records cannot be reviewed since the lot number is unknown.A definite root cause cannot be determined with the information provided.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: UNKNOWN BURR INSTRUMENT
• Type of Device: INSTRUMENT, SURGICAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8086699
• MDR Text Key: 127801724
• Report Number: 0001822565-2018-06520
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 32810502704
• Device Lot Number: 61883946
• 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 Weight: 88