MAUDE Adverse Event Report: SYNTHES SELZACH 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER; DRILL, BONE, POWERED

Catalog Number 03.505.041

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

Additional product code: dzj.(b)(4) lot unknown.Device is an instrument and is not implanted/explanted.It is unknown if the complainant part is expected to be returned for manufacturer review/investigation, but it has not yet been received.(b)(6).(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016, the patient underwent sagittal split ramus osteotomy (ssro).The drilling area was from left mesial side of mandible to the most distal screw-hole.When the surgeon was drilling a hole to insert a screw, the drill bit in question broke at the tip.The broken fragment remained in the bone, so the surgeon additionally cut the bone, and then the fragment was removed.The surgeon took off all the screws which had already been fixed to the plate and displaced and fixed it again because the plate could not be fixed at the same place.The surgery was delay about sixty (60) minutes, and the anesthetic time was extended.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis (b)(4).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.Review of the device history record(s) showed that there were no issues during the 03.505.041 - f-19588: manufacturing location: (b)(4); supplier: (b)(4); manufacturing date: 17.Aug.2016.A product development investigation was performed.The drill bit ø1.5 (03.505.041 / f-19588) was received for investigation.Upon visual inspection of the complaint device it can be seen that the drill bit is broken, thus confirming the complaint description.There is no particular information what happened to this article.We are not able to determine the exact reason for this occurrence, but we have to assume that wear and tear and/or that the drill bit got in contact with hard material (metal) which led to this damage.Also, as this part is not a single use instrument, it cannot be determined how many times it has been used.Further microscopic investigation has shown that the drill bit is badly worn.The drill bit point center is dull, the cutting edges are dull, and has deformation/dents.Based on these damages, the drill bit isn't able to cut anymore.A device history record (dhr) review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.The part was manufactured in august, 2016.No ncrs were marked in the dhr during production.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 DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6106801
• MDR Text Key: 60037293
• Report Number: 2520274-2016-15405
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.041
• Device Lot Number: F-19588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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 Outcome(s): Required Intervention