MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12X75 UNIF A NL UNIV-IL; TRAUMA FIXATION

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that during a procedure ,the sterile packaging of the item was damaged, thus the sterility was compromised, and another nail was used to complete the procedure.The result of the packaging components (clear end cap, inner pouch, outer pouch, and carton) display that the puncture was a result of an extreme drop because the punctures all line up and are the same size.It can be determined that the product left biomet conforming because it has to meet inspection criteria i00051, which says that no holes in any of the packaging are allowed.Review of complaint history found no additional related issues for this item.Review of device history records found these units were released to distribution with no deviations or anomalies.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 during a procedure, the sterile packaging of the item was damaged thus the sterility was compromised.Another nail was used to complete the procedure.

• Brand Name: 12X75 UNIF A NL UNIV-IL
• Type of Device: TRAUMA FIXATION
• 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: 6903586
• MDR Text Key: 87878073
• Report Number: 0001825034-2017-07478
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK982953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2018
• Device Model Number: N/A
• Device Catalogue Number: 344275
• Device Lot Number: 288440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1