MAUDE Adverse Event Report: SYNTHES GMBH MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number	03.511.246
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: erl, hbe.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, three (3) 1.5mm drill bit with 8mm stop, one (1) 1.5mm drill bit with 6mm stop, one (1) matrix drill bit, and one (1) 1.5mm 2 flute drill bit broke during an unknown procedure.The drill bits did not fit properly through the customer cutting guide for the patient specific plates.The drill fit through when placing them through by hand but it was a tight fit resulting in burring of the titanium cutting guide and breakage of the drill bits.The procedure was successfully completed using a transbuccal 1.5mm drill bit.Fragments were generated and easily removed without additional intervention.Patient outcome is unknown.Concomitant device reported: unknown cutting guide (part# unknown; lot# unknown; quantity: 1).This report is for one (1) matrix 1.4mm drill bit j-latch/6mm stop/44.5mm.This is report 3 of 6 for (b)(4).

• Brand Name: MATRIX 1.4MM DRILL BIT J-LATCH/6MM STOP/44.5MM
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11394724
• Report Number: 8030965-2021-01495
• Device Sequence Number: 1219288
• Product Code: DZI
• UDI-Device Identifier: 07611819376755
• UDI-Public: (01)07611819376755
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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 Catalogue Number: 03.511.246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1