MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.; TRAUMA, INSTRUMENT

Catalog Number 00249003244

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Product not returned.

Event Description

It was reported that during the procedure, the reamer fractured and a piece had to be removed from the patient's wound.It was noted that the patient had hard bone which contributed to the reamer fracture.

Event Description

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

Manufacturer Narrative

Udi - (b)(4).Report source foreign - canada.Complaint sample was evaluated and the reported event was confirmed.Product was returned and evaluated.The reamer is fractured and exhibits wear.Device history record was reviewed and no discrepancies were found.Root cause determined to be use error.It was relayed that, "because of the hard bone the surgeon decided to mallet the reamer forward while the power was off.Then he tried to start the reamer when it was lodged in the bone and this is when the tip of the reamer broke.Surgeon admitted that he did not follow surgical technique and this was a factor in the broken reamer." 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: CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8216934
• MDR Text Key: 132055671
• Report Number: 0001822565-2019-00056
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00249003244
• Device Lot Number: 64035388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR