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

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign-(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 mdr will be submitted.

Event Description

It is reported that during incoming product inspection they found a package with air bubbles in the sterile seal.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed; the seal of the packaging is acceptable per criteria.Dhr was reviewed and no discrepancies were found.The device analysis indicated that the device met specification.After product evaluation this is no longer considered a reportable event as there is no product failure.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 additional information received.

• Brand Name: 2.7X160MM CALIBRATED DRILL STE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8059899
• MDR Text Key: 127003757
• Report Number: 0001825034-2018-10521
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• 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: 395950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1