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 Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Additional device product code is dzj.Device is an instrument and is not implanted/explanted.(b)(4).Potential nerve damage and additional medical intervention to retrieve drill bit fragment.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery for upper and lower jaw deformity, the tip of drill was broken.After temporary fixation of the four holes on both sides of the bending template for matrix orthognathic lock sagittal spilt plate (curved) and bite alignment check, the surgeon attempted to drill the rest of the hole and the tip of the drill broke.The drill tip fragment was retained in the patient but was unnoticed by the surgeon at the time.The surgeon then inserted an unknown 5mm length screw into the same hole.The approximately 2mm drill tip fragment was pushed further inside the patient by the screw until it reached an approximate 7mm depth from the bone surface and entered above the neural tube.The surgeon was concerned that the fragment might cause, or had caused, nerve damage and removed the fragment.There was two hour surgical delay due to removal of the fragment.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: product investigation summary: one (1) drill bit 1.5mm w/stop (part: 03.505.041 / lot: f-14998) was received for investigation.The complaint condition for the drill bit is confirmed as the distal tip is broken off and cutting edges are blunt.The manufacturing document shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The device met the specifications at the time of manufacturing and distribution in january, 2014.The used material was stainless steel as required and the measured hardness was within specifications.The broken surface is homogenous, which indicates material conformity as well.Based on the returned condition of the device, it is likely that accumulated wear, in combination with a mechanical overload situation, caused the breakage of the delicate 1.5mm drill bit.Please note: it is important to check instruments for sound surfaces, correct adjustment, and function prior to use.Severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces should not be used during surgery.Based on the manufacturing investigation results, the cause of failure was not due to any manufacturing-related non-conformances.No indication for product related issues was found.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 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 CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5766720
• MDR Text Key: 48710966
• Report Number: 3000270450-2016-10163
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-14998
• Other Device ID Number: (01)07611819187597(10)F-14998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• 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
• Patient Outcome(s): Required Intervention