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
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Concomitant medical products: unknown blade, part# ni, lot# ni.Occupation ¿ patient.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
Event or Problem Description
It was reported the screws could not be grasped by the blade and the screws fell off the blade during a procedure.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The customer returned qty one 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.This report is being submitted to update additional information in section d4, h2, h3, h6 and h10.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10532248
• Report Number: 0001032347-2020-00440
• Device Sequence Number: 16949397
• Product Code: HWC
• UDI-Device Identifier: 00841036054700
• UDI-Public: 00841036054700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2024
• 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: 09/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1