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 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.0001825034-2018-11247.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 air bubbles were found in the seal of sterile package during incoming inspection.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that packaging identified a void in the sterile pouch seal.There was debris within the void of the seal.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due 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: 8187253
• MDR Text Key: 131310600
• Report Number: 0001825034-2018-11251
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 214227160
• Device Lot Number: 997900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1