MAUDE Adverse Event Report: SYNTHES MONUMENT DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC; BIT, DRILL

Catalog Number	03.010.228
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier and weight not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part # 03.010.228 lot # u238342.No ncr's 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.Release to warehouse date: 29 jun 2016.Supplier: (b)(4).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 or Problem Description
Device report from synthes europe reports an event in the (b)(6) as follows: it is reported during an unknown surgical procedure on (b)(6) 2017, after drilling for the second recon screw and removing the drill bit, it was noticed a portion of the drill bit had been left behind.The incision was extended to facilitate the surgeon¿s attempt to remove the fragment.Surgeon determined it would be detrimental to the patient to remove the fragment.The broken fragment of the drill bit is stainless steel and is now embedded in patient bone next to a titanium screw.Surgery was delayed approximately 30 minutes due to the attempt to remove the fragment.Concomitant devices reported: recon screw (quantity 1).This report is for one (1) drill bit for recon screws.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(6).Product development investigation was completed.A visual inspection, device history records review, and hardness test were performed as part of this investigation.This complaint is confirmed.The evaluation of the received drill bit has shown that it is in a very used condition, there are many stress marks all over the shaft and the coupling adapter is worn.The cutting edges damaged and are completely blunt.This finding does indicate the either the use of a blunt instrument or an excessive metallic contact did lead to a mechanical overload and finally the breakage of the drill bit.The relevant dimensions of the drill bit could not be checked as the breakage occurred at the crossover from the smaller to the bigger diameter and as the broken portion is not available.The review of the manufacturing documents has shown that these dimensions were checked during the final inspection and were within the specification.The manufacturing papers showed no deviations regarding, dimensions, material and hardness.The correct material, 440a stainless steel per drawing was used and the hardness was with 51.64 hrc within the specification of 50-55 hrc.The fracture face is homogenous, which indicates material conformity as well.No product fault could be detected.The lot in question was manufactured with a lot size of (b)(4) pieces in june 2016 and we are not aware of any other complaint for this article- and lot number.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.

• Brand Name: DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6552729
• Report Number: 1719045-2017-10439
• Device Sequence Number: 1089671
• Product Code: HTW
• UDI-Device Identifier: 07611819307711
• UDI-Public: (01)07611819307711(10)U238342
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.228
• Device Lot Number: U238342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR