MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X3.5MM HT SD X-DR SCR EA; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Catalog Number 91-6103

Device Problem Difficult to Insert (1316)

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

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 1.5x4mm ht sd x-dr scr ea; cat# 91-6104; lot# j327370.Report source: (b)(6).A visual inspection was completed on both of the returned screws.The tips for both screws are missing.The screws both show signs of attempted use including marking on the screw heads as well as damage to the tips and the surrounding anodize.A determination cannot be made as to what caused the damage to the screw tips.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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: 0001032347-2022-00022.

Event Description

It was reported when the surgeon went to implant the screws, the tip of the screw did not insert correctly.The surgeon changed out the screws and proceeded with the case.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 1.5X3.5MM HT SD X-DR SCR EA
• Type of Device: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13192768
• MDR Text Key: 286059861
• Report Number: 0001032347-2022-00021
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036053727
• UDI-Public: (01)00841036053727(10)737860
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 91-6103
• Device Lot Number: 737860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2020
• 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