MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number	317.82
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient ethnicity is unknown.Additional procodes: erl, hbe.Lot number is unknown.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.Facility name and contact information is unknown.Reporter is a synthes sales consultant.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, two (2) drill bits broke during a mandibular osteosynthesis procedure.One of the fragments was recovered by hand, the other fragment was removed with suction.It is unknown if there was any surgical delay.There was no patient consequence reported.This report is for a 1.5mm drill bit/mini qc with 12mm stop/44.5mm.This is report 2 of 2 for (b)(4).

• Brand Name: 1.5MM DRILL BIT/MINI QC WITH 12MM 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: 7634909
• Report Number: 8030965-2018-54596
• Device Sequence Number: 18876100
• Product Code: DZI
• UDI-Device Identifier: 10887587038773
• UDI-Public: (01)10887587038773
• Combination Product (Y/N): N
• 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 Caregivers
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 317.82
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 65