MAUDE Adverse Event Report: SYNTHES SELZACH Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL; DRILL, BONE, POWERED

Catalog Number 03.505.076

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Pain (1994); Sedation (2368); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 country as follows: it was reported that during the surgery, the tip of the drill bit was broken.The following is the detail of the event; the surgeon was implanting the plate using contra angle driver.When he was inserting the screws at the gonial angle section, he could make the holes and inserted the screws till the third screws; however, the tip of the drill bit was broken while drilling the fourth hole.The surgeon tried to remove the fragment tip; but it was not successful.The fragment tip remained in the lower jawbone.There was a 30 minutes surgical delay.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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

Patient identifier, gender, and weight are unknown.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: january 7, 2010.A review of delivery order for this part/lot combination showed no deviations or non-conformances during manufacturer.Device report from synthes (b)(4) reported the event from (b)(6).(b)(4).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.

Event Description

Device report from synthes (b)(4) reported the event from (b)(6).Concomitant device(s) reported: matrixmandible plate (part/lot: unknown / quantity: 1).

Manufacturer Narrative

Product investigation summary: the drill bit reported in this complaint was returned in a broken condition.The whole front portion of the bit should be 8mm in length.The tip section is broken away with a small remaining piece.Cutting is no longer possible with this device.The exact root cause for this complaint was not defined; however, it is most likely that too much applied force led to this breakage.Further, the use of a competitor¿s power tool product, which may not have had enough speed, to drill could have caused this complaint, too.The device was worn out from normal use and service.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: Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL
• 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: 5776972
• MDR Text Key: 49021511
• Report Number: 3000270450-2016-10165
• 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,Followup,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.076
• Device Lot Number: F-10057
• Other Device ID Number: (01)07611819353596(10) F-10057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2010
• 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
• Patient Age: 87 YR