MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.1MM DRILL BIT/MINI QC WITH 4MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number	317.240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient information is not available for reporting.Additional device product codes: erl, hbe.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter¿s phone number is not provided for reporting.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a craniotomy surgery on (b)(6) 2018, while drilling for patient specific implant (psi) the tip of the drill bit broke and the broken fragment was not retrieved.The surgical procedure was successfully completed.There was no surgical delayed reported.Patient outcome was unknown.This report is for one (1) 1.1mm drill bit/mini qc with 4mm stop/44.5mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 1.1MM DRILL BIT/MINI QC WITH 4MM STOP/44.5MM
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7844006
• Report Number: 8030965-2018-56145
• Device Sequence Number: 19167120
• Product Code: DZI
• UDI-Device Identifier: 10887587038414
• UDI-Public: (01)10887587038414
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 317.240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention