MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM 3-FLUTED DRILL BIT QC/200MM; BIT, DRILL

Catalog Number	03.120.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no reported patient involvement.It is unknown when device broke.Device is an instrument and is not implanted/explanted.Reporter email address is unknown.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review 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 or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date, the drill bit was found broken during decontamination at the sterile department.There is no reported patient or procedure involvement.This report is for a 2.8mm 3-fluted drill bit qc/200mm.This is report 1 of 1 for (b)(4).
Additional 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.A device history record (dhr) review was conducted for part: 03.120.041, lot: 9485127: manufacturing site: bettlach, release to warehouse date: 06.May.2015, sub-component 60030147, lot 9144965 was also manufactured in bettlach, release to warehouse date: 02.Oct.2014: the device history record shows this lot of 120 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and material conformity criteria at the time of release with no issues documented during the manufacturing process.The used raw material 60034880, round 4.65mm 440a was hardened during manufacturing process according to the specification.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.A product investigation was conducted.Visual inspection: the received drill bit shows that approximately 17 mm from the fluted tip section is broken off.The broken off portion is missing.On the shaft are slightly scratches visible.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no drawing/specification review is needed.Material review: the used material was stainless steel as required and the measured harness was with within the specification.The broken surface is homogenous what indicates material conformity as well.Summary: the received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information we are not able to determine the exact cause of this complaint.We only can assume that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.Please also note; blunt drill bits require more mechanical power during the application, therefore we would like to draw your attention on page 4 in the leaflet ¿important information¿ version se_023827 al: 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.We conclude that the cause of failure is not due to any manufacturing non-conformances.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.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: 2.8MM 3-FLUTED DRILL BIT QC/200MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7626587
• Report Number: 8030965-2018-54504
• Device Sequence Number: 1186904
• Product Code: HTW
• UDI-Device Identifier: 10886982074294
• UDI-Public: (01)10886982074294
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.120.041
• Device Lot Number: 9485127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1