MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPOSITCP 60 11X30MM INT. SCR; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation as the product remains implanted.Review of device history records found these units were released to distribution with an unrelated deviation or anomaly.Review of complaint history found no additional issues for this part/lot.Further evaluation of the expiry date and sterility of the product with the supplier noted that was no risk if used within 10 days of expiration date, since the package shelf life ensures sterility of products for more than five years after date of manufacture.The root cause attributed to failure to follow instructions.Risks associated with reported condition are addressed through the warnings in the instructions for use as a part of design control risk management.Associated instructions for use for the composite cp 60 interference screw, under recommendations for devices supplied sterile," it states that "prior to use of the device, the "sterile until" date on the packaging should be checked." following review, no new risks were identified.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 an initial acl procedure, an expired product was implanted into the patient on (b)(6) 2015.This was discovered after the procedure was completed.There were no complications during the procedure itself.No additional patient consequences were reported.

• Brand Name: COMPOSITCP 60 11X30MM INT. SCR
• Type of Device: SCREW, FIXATION, BONE
• 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: 6915397
• MDR Text Key: 88462934
• Report Number: 0001825034-2017-07867
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2014
• Device Model Number: N/A
• Device Catalogue Number: 905263
• Device Lot Number: 112987
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2011
• 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