MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM THREE-FLUTED DRILL BIT QC/195MM; BIT, DRILL

Catalog Number 315.400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information available for reporting.Device is an instrument and is not implanted/explanted.Device is available for evaluation.Reporter telephone number is unavailable.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 a femoral diaphyseal fracture repair occurred on (b)(6) 2018 where several device malfunctions occurred intraoperatively.Although distal femoral nail (dfn) spiral blade was preoperatively tested and passed in dry condition, the dfn blade interfered with the nail.Additional reattempts utilizing guide-wire re-insertion did not succeed, either.The blade fixation was finally abandoned, and the nail was successfully fixed with locking screws.As the surgeon moved on to manual fixation on the proximal side of the nail, it took extra time because the drill bit could not drill to the bone.Two (2) drill bits were tried.The surgery was completed within a 30-minute delay.Patient status is unknown.This is report 2 of 4 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.Reporter email address is unknown.Part: 315.400; lot: 2573920; manufacturing location: bettlach; release to warehouse date: february 25, 2010; no nonconformance 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.Investigation selection investigation site: cq zuchwil; selected flow: 3.Will not cut/dull visual inspection: the complaint condition for the drill bit is confirmed, as the distal tip and cutting edge are blunt and in a very used condition.The shaft or coupling otherwise are still in good condition.Dimensional inspection: because of the damages, the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the wear sings at the tip and cutting edges have no influence on the design, therefore no drawing/specification review will be performed.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.We assume the product was an often and intensively used instrument and the complaint condition was caused by regular wear during its seven (7) years of lifespan.In this regard, we would like to draw your attention to page 4 in the leaflet ¿important information¿: 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-conformances.It has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Code 3191 used to capture surgical delay of thirty (30) minutes.Patient codes 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: 4.0MM THREE-FLUTED DRILL BIT QC/195MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7446935
• MDR Text Key: 106064817
• Report Number: 8030965-2018-53250
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819048287
• UDI-Public: (01)07611819048287
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315.400
• Device Lot Number: 2573920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1