MAUDE Adverse Event Report: ZIMMER BIOMET, INC. A.L.P.S. DRILL; INSTRUMENT, TRAUMA

Catalog Number 829029170

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified that there is an inclusion on the tip protector inside the sterile package.No debris was found in the package.Dhr was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to manufacturing deficiency.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

It was reported that there was an inclusion on the tip protector inside the sterile package.There was no patient involvement.

• Brand Name: A.L.P.S. DRILL
• Type of Device: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8203041
• MDR Text Key: 131743749
• Report Number: 0001825034-2018-11558
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 829029170
• Device Lot Number: 540670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1