MAUDE Adverse Event Report: ZIMMER BIOMET, INC. A.L.P.S ANATOMIC FIBULA LOCKING PLATE 4 HOLE RIGHT; PLATE, FIXATION

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).(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.Expected, not yet received.

Event Description

It was reported during incoming inspection at the warehouse that the sterile packaging was found to be "sticky." there was no patient involvement.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

(b)(4).Examination of the reported device packaging confirms the reported sticky residue from lot label adhesive and label backing.Review of device history records did not identify any related manufacturing deviations or anomalies.The root cause is manufacturing error.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.

• Brand Name: A.L.P.S ANATOMIC FIBULA LOCKING PLATE 4 HOLE RIGHT
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7966607
• MDR Text Key: 123744774
• Report Number: 0001825034-2018-09718
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• 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: 04/01/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 856207004
• Device Lot Number: 885000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1