MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SYS SMALL BONE FIXATION 1.6MM; TRAUMA IMPLANTS

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Based on device history records, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.The inner packaging seal was unsealed as stated in the complaint.Upon further inspection with packaging engineers, the inner packaging was determined to be definitely sealed at one point, as shown in the attached ¿photo of seal¿.Review of the complaint history identified additional complaints (wpc (b)(4)) that were investigated, and it was determined that no further action is required due to the issue was identified as a supplier problem and has since been resolved.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 metacarpal fracture procedure on (b)(6) 2015, the external packaging was opened and the plastic tray fell out of the inner packaging as the seal was not sealed.The bottom side was not sealed and therefore the product was not sterile.Another product of the same lot was used to complete the procedure without delay.

• Brand Name: SYS SMALL BONE FIXATION 1.6MM
• Type of Device: TRAUMA IMPLANTS
• 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: 6937237
• MDR Text Key: 90070704
• Report Number: 0001825034-2017-08361
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Model Number: N/A
• Device Catalogue Number: SBFS062
• Device Lot Number: AU4220138
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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