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 07/14/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: dzj.(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4).Subject device has not been received.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.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that during ssro (sagittal split ramal osteotomy), the tip of the drill bit broke when the surgeon was drilling the most proximal screw hole.The fragment tip remained in the patient body.As the fixed area was near the mandibular canal, the patient is under follow up and the surgeon suggest that a revision would be necessary if any effect occurred.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product investigation including was performed for the subject device (1.5mm dia drill bit w/6mm stop 13mm length f/90° screwdriver, part number 03.505.041, lot number f-14998).The subject device was received for investigation with the complaint stating that during ssro (sagittal split ramal osteotomy), the tip of the drill bit broke when the surgeon was drilling the most proximal screw hole.The fragment tip remained in the patient body.As the fixed area was near the mandibular canal, the patient is being monitored and the surgeon suggested that a revision would be necessary if any effect occurred.The visual inspection of the returned drill bit has shown that approximately 4 mm from the fluted tip section is broken off.The broken off portion was not returned (remains in the patient¿s body).The complaint condition is confirmed.Because of the damage the complaint relevant dimensions cannot be checked to print specifications.The device history record review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The subject device material is (b)(4).The measured harness was with (b)(4) hv within the specification of (b)(4) hv.The broken surface is homogenous what indicates material conformity as well.Based on the provided information an exact root cause of the complaint condition cannot be determined.It is likely that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.Please also note; blunt drill bits require more mechanical power during the application, per the leaflet, important information, ¿check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.¿ based on the manufacturing investigation results it is concluded that the cause of failure is not due to any manufacturing non-conformances.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5848201
• MDR Text Key: 51223329
• Report Number: 2520274-2016-13918
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/19/2016

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: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/12/2016
• 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