MAUDE Adverse Event Report: SYNTHES SELZACH Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED

Catalog Number 03.505.075

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2014, the surgeon was drilling with a contra-angle driver to fix fracture of mandible, the tip of the drill bit in question broke.A broken piece was left in the patient's bone, and the operation was finished.No surgical delay was reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted explanted.Device received by manufacturer on january 5, 2015.(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Also, a review of the device history records has been 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.

Manufacturer Narrative

Device history records was conducted.The report indicates that no ncrs were generated during production.Review of the device history record (s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The manufacturing location for the supplier is (sphynx).Reported as 01/07/2013 on follow-up.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.

Manufacturer Narrative

A manufacturing evaluation was performed for the returned device.The returned article was examined.The tip of the drill bit was broken as complained.Though a root cause could not be exactly confirmed, it is possible that the application of excess mechanical force resulted in this damage or another reason is that the drill bit could have come in contact with hard surface (bone or metal).This drill bit was manufactured to specification and met all release criteria in january 2010.This drill bit, due to its design and size, needs to be handled with care.No actual product fault could be found with this article.Report was initially submitted on february 23, 2015 but the fda site was down.Advised by fda on march 2, 2015 to resubmit medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: Ø1.5MM DRILL BIT W/6MM STOP 13MM F/90° SCRWDRVR MTRXMANDBL
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4376463
• MDR Text Key: 5284288
• Report Number: 2520274-2014-15674
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.075
• Device Lot Number: F-10175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1