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 08/02/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the drill bits broke during surgery.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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 has been requested.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

Additional manufacturing date: july 22, 2013.A manufacturing evaluation was completed: the devices were received broken distal.Both damaged drill bits were checked and found to be in compliance with the technical drawings and ao/asl f specification.The examination of the raw-material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard (1.4112).Our investigation for both instruments have shown that the tips are contorted, broken distal and the cutting edges are blunt.There is no evidence regarding location of both tips.It is likely that too much mechanical force or possible contact with other metallic parts during drilling may have caused these damage.No product fault could be detected.A review of the device history records was completed: (b)(4).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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4051737
• MDR Text Key: 21729206
• Report Number: 1719045-2014-10413
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.510
• Device Lot Number: U172700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2013
• 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