MAUDE Adverse Event Report: SYNTHES MONUMENT 1.8MM DRILL BIT/QC/100MM; DRILL, BONE, POWERED

Catalog Number 310.510

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Additional device product code used hsz.Device is an instrument and is not implanted / explanted.(b)(6).Device history records review was completed for part # 310.510, lot # u197854.Release to warehouse dates: apr 25, 2014 and may 19, 2014.Manufacturer: (b)(4), supplier: (b)(4).No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, the drill bit broke during surgery.No delay in surgery and no patient harm were reported.This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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 Description

The broken drill bit was recognized during cleaning process at the loan department.The event was not reported by the hospital/surgeon.

Manufacturer Narrative

Product investigation was completed for part # 310.510, lot # u197854.The returned drill bit was received at customer quality (cq) in two pieces.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.The break angle is slightly oblique and the fractured tip fragment measured approximately 4.5mm using calipers.The fluted tip outside diameter nearest the break measured 1.79mm which is with specification of 1.786mm - 1.81mm per product drawing.No product design issues or discrepancies were observed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.The 310.510 drill bit ø1.8 l100/75 2 flute is an instrument used to pre-drill for the core diameter of 2.0mm screws and is available for use in multiple depuy synthes systems.A definitive root cause cannot be determined.Most likely due to off axis forces or use of a previously dull/worn drill bit thereby requiring excessive axial force resulting in the break.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.

• Brand Name: 1.8MM DRILL BIT/QC/100MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6092114
• MDR Text Key: 59572693
• Report Number: 1719045-2016-10818
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 310.510
• Device Lot Number: U197854
• Other Device ID Number: (01)07611819018808(10)U197854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• 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