MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 3.5 MM HEX HEAD PROSTHESIS, TRAUMA

Catalog Number 47248310560

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Report source: event occurred in (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. 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 approximately three weeks ago, the surgeon opened the outer packaging of the screw to discover the screw broken through the inner sterile packaging. Surgeon used a backup screw to complete the surgery. Attempts have been made and no further information has been provided.

• Brand Name: 6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 3.5 MM HEX HEAD
• Type of Device: PROSTHESIS, 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: 12569027
• MDR Text Key: 274517850
• Report Number: 0001822565-2021-02841
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 47248310560
• Device Lot Number: 62462893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI