MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM DRILL BIT/QC WITH 65MM STOP; 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	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that during a neurosurgery procedure on (b)(6) 2019, the drill bit broke when the massa lateralis (c5) was perforated.Surgery completed using awl.No harm to patient; minimal delay in surgery.This report is for a 2.4 mm drill bit.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 review of the device history record.Device history lot : part # 388.394.Synthes lot # u207108.Supplier lot # u207108.Release to warehouse date: 16 sep 2014.Supplier: orchid unique.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No ncr's were generated during production.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation site: cq zuchwil.Selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the evaluation of the received drill bit has shown that a piece of about 13mm length is broken off.The fragment was not returned for investigation.Otherwise is the drill bit in good condition, just slight wear marks are at the coupling piece visible.Dimensional inspection: summary: the complaint is confirmed as the drill bit is broken as complained.This lot of 268 pieces was manufactured in september 2014 and we are not aware of any other complaint for this article- and lot number combination.This and the findings above let us exclude a manufacturing related issue.Based on the provided information and without the fragment the exact cause of this occurrence cannot be defined.We can only assume that a mechanical overload during use did lead to the breakage of this device.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
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.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 WITH 65MM STOP
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8892806
• Report Number: 8030965-2019-67217
• Device Sequence Number: 1628105
• Product Code: HTW
• UDI-Device Identifier: 07611819752931
• UDI-Public: (01)07611819752931
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 07/17/2019

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: U207108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/14/2019; 09/12/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/11/2019; 10/03/2019
• Patient Sequence Number: 1