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 Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 procedure on (b)(6) 2020, the synapse drill bit broke and was inserted into the patient's cervical spine.Procedure outcome and patient status are unknown.This report is for a 2.4mm 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.H3, h6: 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.
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, h6: part number:388.394, synthes lot number: u242616, supplier lot number: n/a, release to warehouse date: march 17, 2016, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.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.Visual inspection: the evaluation of the received drill bit has shown that a piece of approx.19mm length is broken off.The broken off 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: checked dimensions with caliper 3-03-17585.Outer diameter specification 2.4mm 0/-0.05 / measured: 2.37mm = pass.Overall length (measured with a ruler to define length of missing piece) specification 205mm +/-1 / measured: 186mm = damaged post-manufacturing.Drawing/specification review: the drawing was reviewed during the evaluation to verify the measurements, the material and the hardness.The review of the manufacturing documents has shown that with 440a stainless steel the correct material was used and that the hardness was with 51.6 hrc within the specification of 50-55 hrc from drawing.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.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.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.

• 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: 10295042
• Report Number: 8030965-2020-04983
• Device Sequence Number: 19488984
• Product Code: HTW
• UDI-Device Identifier: 07611819752931
• UDI-Public: (01)07611819752931
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 388.394
• Device Lot Number: U242616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 08/18/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/13/2020; 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention