MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X 7MM DIR-DRV LACT SCW 2PK; PROSTHESIS, MICROFIXATION

Catalog Number	915-2201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00251.0001032347-2021-00252.0001032347-2021-00253.Item# 915-2200; lot# 893220.Item# 915-2200; lot# 893220.Item# 915-2201; lot# 893660.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 or Problem Description
It was reported approximately three (3) weeks ago that a patient underwent an initial segment procedure.During implantation, the screwhead did not fit tight.Attempts have been made and no further information has been provided.
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.Upon reassessment of the reported event and additional information received, it was determined to be not reportable.The incorrect quantity was reported and this malfunction does not have a true sentinel event for this product line.The initial report was forwarded in error and should be voided.

• Brand Name: 2.0X 7MM DIR-DRV LACT SCW 2PK
• Common Device Name: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11787188
• Report Number: 0001032347-2021-00254
• Device Sequence Number: 3460710
• Product Code: HWC
• UDI-Device Identifier: 00841036054700
• UDI-Public: (01)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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 09/25/2025
• Device Catalogue Number: 915-2201
• Device Lot Number: 893660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10