MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 17.8MM DRILL BIT LARGE QC/312MM; BIT, DRILL

Catalog Number 309.600

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales consultant.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 the cutting edge of the drill bit was damaged on an unknown date.It is not known if there was patient or surgical involvement.This report is for one (1) drill bit.This is report 1 fo 1 for (b)(4).

Event Description

It was reported that on an unknown date, before an unknown procedure, the cutting edge of the drill bit was broken.The procedure was completed successfully with ten (10) minutes surgical delay.There was no other medical intervention required.The patient outcome after the procedure was unknown.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5: updated event description.E1: reporter's phone, email reported.H3, h4, h6: a device history record (dhr) review was conducted: part: 309.600.Lot: f-12423.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 24.Sept.2012.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Ncr# 3143806 was generated during production.This non-conformance is not relevant to the complaint condition since 28.Feb.2012.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.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection has shown that the one cutting tip of three is broken off.The cutting edges of the drill bit are in a used condition.Dimensional inspection: the relevant features are heavy damaged in a manner which prevents accurate measurement of the features.Drawing/specification review: not required per selected investigation flow as root cause is use related.Material review: not required per selected investigation flow as root cause is use related.Summary: the visual inspection has shown that the drill bit tip is broken.Therefore, this complaint is rated as confirmed.Unfortunately we are not able to determine the exact cause of this complaint.The cutting edges of the drill bit are in a used condition.The broken surface is homogenous what indicates material conformity to the specification as well.Based on the provided information we are not able to determine the exact cause of this complaint.The wear and tear indicate that the product was often and intensive used instrument.We do suppose that the cause of the breakage is the result of a mechanical overload situation during use.Also prevent possible contact with other metallic parts during drilling may have caused these damages.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.H11 corrected data: e1: reporter's name; e3.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: 17.8MM DRILL BIT LARGE QC/312MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8204158
• MDR Text Key: 131713606
• Report Number: 8030965-2018-59311
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819292895
• UDI-Public: (01)07611819292895
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.600
• Device Lot Number: F-12423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1