MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X7MM BONE REDUCTION BLADE; ORTHOPAEDIC KNIFE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2020
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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(4).
Event or Problem Description
It was reported the screw tip broke during an open reduction and internal fixation of a zygomatic fracture.The screw tip remained in the body without reduction.The bone was scraped and the screw tip fragment was removed from the patient.It was reported that no further information was available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d1, d2, d4, h4 the following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h10 quantity of one 2.0x7mm bone reduction blade was returned for evaluation.Visual examination identified the tip to be fractured.The part and lot information were verified.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: 2.0X7MM BONE REDUCTION BLADE
• Common Device Name: ORTHOPAEDIC KNIFE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11086845
• Report Number: 0001032347-2020-00628
• Device Sequence Number: 17046313
• Product Code: HWI
• UDI-Device Identifier: 00841036145491
• UDI-Public: 00841036145491
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• 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): 09/23/2021

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 Model Number: N/A
• Device Catalogue Number: SP-1889
• Device Lot Number: 933340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 09/23/2021
• 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