MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7X160MM CALIBRATED DRILL STE; TRAUMA, INSTRUMENT

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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 report will be submitted.

Event Description

It was reported that debris was found in the sterile package.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned product identified a hair-like debris within the sealed sterile packaging.The complaint is confirmed.Ftir spectrum analysis of the debris concluded it is a biological material and the appearance suggests hair.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to operator error during the manufacturing process.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.

Event Description

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

• Brand Name: 2.7X160MM CALIBRATED DRILL STE
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9450265
• MDR Text Key: 189332678
• Report Number: 0001825034-2019-05530
• Device Sequence Number: 1
• Product Code: HTW
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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: 214227160
• Device Lot Number: 815650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1