MAUDE Adverse Event Report: SYNTHES MONUMENT 1.5MM DRILL BIT 12MM STOP/52MMHXC; DRILL, BONE, POWERED

Catalog Number 316.652

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that a drill bit broke during a chin implant surgery.The broken bit remains in the patient.There was a fifteen minute delay in surgery.The patient's outcome was reported as good and the surgery was completed successfully.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records was completed: orchid unique manufactured the matrix-mandible 1.5mm drill bit, part number 316.652, and lot u162872.Initially, the part conformed to the supplier¿s certificate of conformance and to the synthes final inspection sheet.There were no material review reports, non-conformance reports, or complaint related issues with this lot.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.

Manufacturer Narrative

Product investigation: one 1.5mm drill bit with 12mm stop, hex coupling, part number 316.652, was received with the complaint category of ¿broken intraoperatively.¿ the returned drill bit has a hex coupling; however, there are multiple coupling variations available for use.This drill bit family is intended for predrilling prior to insertion of a 2.0mm screw in the craniofacial and mandible systems.The returned drill bit, lot number u162872, was manufactured by orchid unique.It was received with approximately 2mm of the fluted portion remaining at the distal tip.The break is perpendicular to the axis of the drill bit and the remainder of the cutting tip was not received.There is wear to the hex drive and the balance of the drill bit shows light surface scratches.Thus, the complaint condition is confirmed but cannot be replicated as the device was received broken.This condition is consistent with the expected result from excessive force outside the recommended surgical technique.In addition, for optimum performance, this device is recommended as single use.If however, the hospital makes a decision to re-use these devices proper visual inspection, cleaning, and sterilization should be observed.Based on the returned condition, the complaint condition is most likely a result of use of a worn device and/or excessive force.Per the supplier certificate of conformance, the drill bit was manufactured to the current drawing revision.The material specification is 440a heat treated per (b)(4) and is acceptable for this use.No drawing issues or discrepancies were noted and the design was found to be sufficient for its intended use.Therefore, this complaint condition is determined to not be the result of a design deficiency.In conclusion, the complaint condition is confirmed.The complaint condition was determined to not be the result of a design deficiency and most likely to be a result of the method of use of a worn device and/or excessive force.The design was found to be sufficient for its intended use.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.

• Brand Name: 1.5MM DRILL BIT 12MM STOP/52MMHXC
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4231566
• MDR Text Key: 20270680
• Report Number: 1719045-2014-10569
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

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: 316.652
• Device Lot Number: U162872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• 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
• Patient Age: 44 YR
• Patient Weight: 59