MAUDE Adverse Event Report: SYNTHES USA Ø1.8MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED

Catalog Number 03.505.084

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No reported patient or surgical involvement.Exact date of device breakage is unknown.(b)(4).Device is an instrument and is not implanted or explanted.Per facility, the complainant part has been discarded and is not available for evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 Description

It was reported that a 19mm matrixmandible drill bit belonging to an evaluation set was found to be broken after sterile processing was completed on an unknown date.There was no reported patient or surgical involvement.This report is 1 of 1 for (b)(4).

• Brand Name: Ø1.8MM DRILL BIT W/12MM STOP 19MM F/90° SCRWDRVR MTRXMANDBL
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5648009
• MDR Text Key: 45034517
• Report Number: 2520274-2016-12643
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1