MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.5 X 7MM 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	10/15/2020
Type of Reportable Event	Malfunction
Additional 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.Distributor on behalf of facility.The user facility is foreign, therefore, a facility medwatch report will not be available.Foreign source: (b)(6).
Event or Problem Description
It was reported the screw could not be grasped and an alternate screw was used to complete the procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
The implant was returned because the direct drive screw could not be grasped.There is clear damage to the screw head.The threads of the screw are not damaged.Dimensional testing was not completed due to damage to the screw head.The complaint is confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.5 X 7MM DIRECT DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10785886
• Report Number: 0001032347-2020-00556
• Device Sequence Number: 3645369
• Product Code: HWC
• UDI-Device Identifier: 00841036054779
• UDI-Public: 00841036054779
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 05/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 915-2208
• Device Lot Number: 769250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 09/14/2021
• 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