MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044; DRILL, BONE, POWERED

Model Number	03.503.461
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2020, during a mandible reconstruction procedure the drill bit broke when the bit was placed in the drill.There was a surgical delay of five (5) minutes.Fragments were generated and easily removed.Another drill bit was used to complete the procedure.The procedure was completed successfully.There was no consequence to the patient.Concomitant device reported: drill (part number unknown, lot unknown, quantity 1).This report involves one (1) matrixmandible 1.8mm drill bit j-latch/90mm for 03.503.044.This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10488365
• Report Number: 8030965-2020-06582
• Device Sequence Number: 2552992
• Product Code: DZI
• UDI-Device Identifier: 10887587012933
• UDI-Public: (01)10887587012933
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: 03.503.461
• Device Catalogue Number: 03.503.461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL