MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Mechanical Problem (1384)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Two screws were returned with damage.One screw has visible damage, while the other one has substantial damage to the head.Item and lot numbers are confirmed to match the product label.Dimensional testing was not completed due to damage to the screw heads.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 due to the inability to dimensionally measure the product due to attempted use.A possible gauge issue was identified and an issue evaluation was previously initiated for further evaluation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00059.Concomitant medical products: 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893690.Report source foreign: (b)(6).

Event Description

It was reported that two (2) screws could not be retained by the screwdriver blade.No adverse events have been reported as a result of the malfunction.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW
• Type of Device: SCREW, FIXATION, BONE
• 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: 11747685
• MDR Text Key: 254485309
• Report Number: 0001032347-2021-00240
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036054700
• UDI-Public: (01)00841036054700(17)250924(10)893690
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011139
• 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
• Report Date: 04/29/2021

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: N/A
• Device Catalogue Number: 915-2201
• Device Lot Number: 893690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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