MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION; BIT,DRILL

Catalog Number 03.010.061

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.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 during an unknown surgical procedure for a femoral trochanteric fracture on (b)(6) 2018, surgeon noted the drill bit seemed to be dull and took extra time to dill compared to another drill bit.Surgery was completed successfully with a delay of approximately 30 minutes.No adverse consequence to the patient.This report is for one (1) 4.2mm three-fluted drill bit.This is report 1 of 1 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: investigation summary investigation selection investigation site: cq zuchwil.Selected flow: 3.Damaged: visual ¿ stripped/worn - will not cut/dull.Visual inspection: the received drill bit is in a used condition.The tip and as well the cutting edges are worn as complained.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.Summary: due the visible damages on the drill bit the complaint condition is rated as confirmed.Based on the provided information we are not able to determine the exact cause of this complaint.It is likely that a mechanical overloading situation, metallic contact or simply regular wear could lead to the visible damages.In this regard,the leaflet suggest that you check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.Based on the manufacturing investigation results we conclude that the cause of failure is not due to any manufacturing non-conformance's.It has been determined that no corrective and/or preventative action is proposed.Additionally, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history.Lot part: 03.010.061.Lot: 9756121.Manufacturing site: bettlach.Release to warehouse date: 30.Dec.2015.The device history record shows this lot of 120 pieces was processed through the normal manufacturing and inspection operations with no rework or non-conformance noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Device history review 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.

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 the device has been 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.

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7967187
• MDR Text Key: 123803756
• Report Number: 8030965-2018-57347
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819760899
• UDI-Public: (01)07611819760899
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.061
• Device Lot Number: 9756121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1