MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM DRILL BIT/QC; BIT,DRILL

Catalog Number	388.394
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, a cervical posterior fixation surgery at c4 was performed.During the surgery, when the surgeon tried to drill for the pilot hole for an unknown lateral mass screw by sizing up to 16 or 18mm, the drill bit broke off.Then, the surgeon used an alternative drill bit to continue drilling, however, the drill bit was also broken.Thus, the surgery was completed by using another alternative drill bit.All broken fragments were removed.There was a 5-minute surgical delay and there was no adverse consequence to the patient.Concomitant devices reported: unknown handle (part # unknown, lot # unknown, quantity of 1).This is report 2 of 2 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.H3, h4, h6: a review of the device history record device history lot part number: 388.394, synthes lot number: u200415, supplier lot number: n/a, release to warehouse date: 05 jun 2014, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation summary investigation selection investigation site: cq zuchwil selected flow: damaged - broken.Visual inspection: the received drill bit shows that that approx.14mm from the fluted tip section is broken off.The cutting edges at the tip are slightly worn.The shaft and coupling are otherwise still in good condition.Dimensional inspection: conclusion: the measuring result does show conformity.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: 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¿ 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: 2.4MM DRILL BIT/QC
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8675981
• Report Number: 8030965-2019-65012
• Device Sequence Number: 2130006
• Product Code: HTW
• UDI-Device Identifier: 07611819752931
• UDI-Public: (01)07611819752931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 388.394
• Device Lot Number: U200415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/08/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - HANDLES