MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD SCREW 2.7MM X 24MM; SCREW, FIXATION

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Four md screw products identifications were reported in conjunction with this event.It is unknown after follow-up attempts which two screws backed out and revised.The information for three other screws is as follows:  item name: md screw 2.7mm x18mm, catalog number: 131227318, lot number: unknown, expiration date: unknown,  manufacture date: unknown.Item name: md screw 2.7mm x20mm, catalog number: 131227320, lot number: unknown, expiration date: unknown, manufacture date: unknown.Item name: md screw 2.7mm x22mm, catalog number: 131227322, lot number: unknown, expiration date: unknown, manufacture date: unknown.Concomitant medical products: item# 131227318; md screw 2.7mm x 18mm; lot# unknown.Item# 131227320; md screw 2.7mm x 20mm; lot# unknown.Item# 131227322; md screw 2.7mm x 22mm; lot# unknown.Item# 131823050; dvr lock wide l; lot# unknown.Item# 131227218; 2.7mm non locking cortical screws; lot# unknown.Item# 131227216; 2.7mm non locking cortical screws; lot# unknown.Item# 131227210; 2.7mm non locking cortical screws; lot# unknown.Item# 131227218; 2.7mm non locking cortical screws; lot# unknown.Report source: foreign (b)(4).Reported event was confirmed by review of x-rays, which identified transverse fracture involving the distal radial diaphysis with dorsal angulation of the fracture fragments.Interval placement of a plate and screw fixation device along the fracture with eventual backing out of one and possibly two screws along the distal plate into the volar soft tissues.Visual examination of the returned plate identified scratches on it, possibly from explantation.A total of ten unknown screws were returned.However, with the help of the family number they have provided and measuring the length of the screw it was possible to determine the part number of the screws.Dimensions taken on all 6 multi-directional screws were conforming to print specifications.Visual inspection of the screws did not show any damage or wear.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: 0001825034-2020-00821.

Event Description

It was reported that patient underwent plating procedure.Subsequently, the patient underwent a revision procedure due to multi-directional screws backing out of a drv crosslock plate 4 months post operatively.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

• Brand Name: MD SCREW 2.7MM X 24MM
• Type of Device: SCREW, FIXATION
• 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: 9739182
• MDR Text Key: 190052844
• Report Number: 0001825034-2020-00819
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 131227324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention