MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.5 LOCKING CORTICAL SCRW 30MM; PLATE, FIXATION

Model Number 8150-45-530

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: 815045545 m14790 a 4.5 locking cortical scrw 45mm; 814131112 146770 femoral plate 12 hole left; 214126035 nm0608 3.5mm hex extractor hudson.Report source: foreign- (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01543.

Event Description

It was reported that during the procedure the locking ring fell off the steel plate and the locking pin slipped.The surgeon removed the plate and removed the screws.While removing the screws the threads stripped and the screw fractured.It was also noted that the extractor instrument fractured.The surgery was delayed by approximately 2 hours to use new products to complete the surgery.Another plate and screws were used to complete the procedure.No harm to the patient has been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h4, h6, h10.Visual examination of the returned product identified that all devices exhibited damage.A screw and the extractor were found to be fractured and the plate was returned with damaged threads and a pin missing from one of the bushing holes.Inspection of the bushing holes found one of the bushings does not sit flush with the plate.The fractured screw underwent further analysis, which showed that the fracture was consistent with fatigue.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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

No further event information available at the time of this report.

• Brand Name: 4.5 LOCKING CORTICAL SCRW 30MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11849880
• MDR Text Key: 251448294
• Report Number: 0001825034-2021-01544
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868040849
• UDI-Public: (01)00887868040849
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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: Health Professional
• Device Model Number: 8150-45-530
• Device Catalogue Number: 815045530
• Device Lot Number: M21688 B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1