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

Catalog Number 03.505.075S

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Additional device product code: dzj.(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as part remains in the patient and part was discarded by the facility.(b)(6).A device history record (dhr) review was performed for part # 03.505.075s, lot # 9110048: please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 22.Aug.2014, expiry date: 01.Aug.2024: no non conformance reports (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.Non-sterile 03.505.075 / f-14554 was manufactured: supplier: (b)(4), manufacturing date: 03.Mar.2014: 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 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 before the end of surgery on (b)(6) 2017, it was recognized that the drill bit had snapped and broke off.The surgeon was unable to retrieve the fragment and decided to leave the fragment in the patient¿s right mandible where it was in order to prevent further surgical intervention.No information available about patient condition and outcome.No surgical delay was reported.This report is for one (1) drill bit.This is report 1 of 1 for complaint (b)(4).

• 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 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: 6756522
• MDR Text Key: 81486456
• Report Number: 3000270450-2017-10271
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.075S
• Device Lot Number: 9110048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2014
• 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