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

Catalog Number 915-2201

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (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.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

It was reported that approximately three and a half (3.5) weeks ago, the screw could not be gripped.Patient did not experience any harm as a result of the event.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.This report is being submitted to update additional information in section d1, d2, d4, d9, d10, e4, h2, h3, h6 and h10.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00240 d10 ¿ medical products 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893690.

Event Description

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

• 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
• MDR Report Key: 11298257
• MDR Text Key: 238622106
• Report Number: 0001032347-2021-00059
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036054700
• UDI-Public: (01)00841036054700
• Combination Product (y/n): N
• PMA/PMN Number: K011139
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1