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 Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Medical products: unknown blade, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).

Event Description

It was reported that the screws could not be retained by a blade during a demonstration with the sales team.There was no patient involvement.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The customer returned qty two 915-2201 lot 775440 lactosorb screw for evaluation due to lack of retention complaint.A visual inspection of the screw showed light signs of attempted use.For further analysis the screw was returned to warsaw for further investigation by the ops manufacturing technician.The reported testing result shows that the returned product was found to fail the no-go test and has been deemed out of spec.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to issues in the manufacturing process leading to undersized parts being manufactured.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.

• 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: 10538756
• MDR Text Key: 207292495
• Report Number: 0001032347-2020-00442
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036054700
• UDI-Public: 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
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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: 775440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE