MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source:foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the screw could not be fully threaded.The surgery was completed with another device, causing a surgical delay of 15 minutes.No further information has been made available.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The following report is being submitted to relay additional information received the complaint can be confirmed based on the returned complaint sample.Visual inspection found the screw head to be damaged.A portion of the head's rim material has been pulled away and detached from the head.The hex feature has also been deformed, indentations can be seen on the inside of the hex.The device history records were reviewed and no related deviations/ anomalies were identified that affect the reported event.A definite root cause cannot be identified if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 ACETABULAR SCREW
• Type of Device: PROSTHESIS, HIP
• 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: 7128790
• MDR Text Key: 95752215
• Report Number: 0001825034-2017-11026
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• 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: 010000999
• Device Lot Number: 6083438
• Other Device ID Number: (01) 0 0880304 52747 8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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