MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BROCA Ø1.5 C/TRAV C13/6 2AREST-CORT; DRILL, BONE, POWERED

Catalog Number	03.505.075
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional classification code: dzj.Device is an instrument and is not implanted/explanted.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.The manufacture date is unknown.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 during an unknown procedure on (b)(6) 2018, the tips of two (2) matrixmandible drill bits broke while drilling the hole.The tips could not be recovered and were left inside the patient¿s bone.There was no patient consequence.It was unknown if there was a surgical delay.Procedure outcome was unknown.This is report 2 of 2 for (b)(4).

• Brand Name: BROCA Ø1.5 C/TRAV C13/6 2AREST-CORT
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7638674
• Report Number: 8030965-2018-54644
• Device Sequence Number: 13809166
• Product Code: DZI
• UDI-Device Identifier: 10887587013619
• UDI-Public: (01)10887587013619
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082649
• 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): 06/01/2018

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: 03.505.075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• 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
• Patient Age: 26 YR
• Patient Weight: 86