MAUDE Adverse Event Report: SYNTHES BETTLACH 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM; BIT, DRILL

Catalog Number 323.062

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

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

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Device 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.(b)(4).The tip of the drill bit broke off and the surgeon left it retained in the patient's bone.A device history record review was performed for the complaint part & device lot.The 323.062 / 9858400.Manufacturing location: (b)(4).Manufacturing date: 10th march 2016.Neither deviation nor any ncrs were marked in this document.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 the reported device was used in surgery for the distal humeral fractures on (b)(6) 2016.By using va (variable angle) drill sleeve, the surgeon tried to drill the second most distal hole on the inner plate.However, the drill sleeve could not be fixed into the hole.The surgeon then tried re-drilling with double drill sleeve 2.7.Because the insertion angle was not properly lined up, he tried re-drilling without taking out the drill completely from the bone.Because the drill was being distorted, the drill tip chipped by approximately 15 mm.He tried to remove the chipped fragment but thought that this removal might have enlarged the drill hole.Therefore, he decided to leave it in the body.The surgery was extended for three minutes.This complaint involves 2 parts.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional narrative: (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.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

The measurable dimension of the diameter of the shaft shows conformity to the specification.Measured hardness and it was found within specification.No manufacturing related issue could be identified.Reviewing the device history records shows that this lot was manufactured according to the specifications and the lot was released after final inspection with no findings.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.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: 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6103151
• MDR Text Key: 59909255
• Report Number: 9612488-2016-10462
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/25/2016

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: 323.062
• Device Lot Number: 9858400
• Other Device ID Number: (01)07611819166264(10)9858400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/09/2016; 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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