MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE STEINEM PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned because it was discarded by hospital.The investigation is in process.Once the investigation  has been completed, a follow-up mdr will be submitted.Discarded by hospital.

Event Description

It was reported that when the device was removed from sterile packaging and placed in wire driver it was noticed that the pin was bowed.Another device was used to complete the surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Upon reassessment of the reported event, it was determined to be not reportable as this component did not cause serious injury and has not previously been reported for causing serious injury.

Manufacturer Narrative

(b)(4).

• Brand Name: COMPREHENSIVE REVERSE STEINEM PIN
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 7393579
• MDR Text Key: 104420327
• Report Number: 0001825034-2018-02295
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 405800
• Device Lot Number: 206740
• Other Device ID Number: (01) 0 0880304 46959 4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 04/23/2018; 06/26/2018
• Supplement Dates FDA Received: 05/18/2018; 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 68 YR