MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 20MM; ORTHOPEDIC BONE SCREW

Catalog Number 010000997

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: g7 screw 6.5mm x 20mm, cat#010000997, lot# 6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot# 6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot# 6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot#6591649.G7 screw 6.5mm x 35mm, cat#010001000, lot#6586581.G7 screw 6.5mm x 20mm, cat#010000997, lot#6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot#6591649.G7 screw 6.5mm x 35mm, cat#010001000, lot#6586581.G7 screw 6.5mm x 35mm, cat#010001000, lot#6586581.Report source: (b)(6).Visual inspection of the returned units for lot # 6591649 found that 3 of 7 units meet the specifications and 4 of 7 units are below the 6mm specification.The reported issue is confirmed for 4 of 7 units.Visual inspection of the returned units for lot # 6586581 found that all 3 units did not meet the seal width specifications.The reported issue is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).The likely condition of the product when leaving zimmer biomet was not conforming to specifications.The root cause of the reported issue is attributed to operator error during the manufacturing process.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00505, 0001825034-2020-00506, 0001825034-2020-00508, 0001825034-2020-00509, 0001825034-2020-00511, 0001825034-2020-00512.

Event Description

It was reported through incoming inspection at the warehouse that the seal width was less than 1/4 inch (6.35mm).No further event information available at the time of this report.

• Brand Name: G7 SCREW 6.5MM X 20MM
• Type of Device: ORTHOPEDIC BONE SCREW
• 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: 9670886
• MDR Text Key: 200431021
• Report Number: 0001825034-2020-00510
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527454
• UDI-Public: (01)00880304527454(17)290714(10)6591649
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000997
• Device Lot Number: 6591649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1