MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM; REAMER

Catalog Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.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.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 the (b)(6) as follows: it was reported the 6.0mm/10.0mm stepped drill bit (reamer) from the trochanteric fixation nail (tfn) set broke during an unknown surgical procedure on (b)(6) 2018.This report is for one (1) 6.0mm/10.0mm stepped drill bit.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: 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
It was reported that a broken fragment from the device remained in the patient¿s proximal femur.There was a thirty (30) minute delay but the procedure was completed successfully.
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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.A device history record (dhr) review was performed for part number: 03.221.015, synthes lot number: u212263, supplier lot number: u212263: release to warehouse date: 13-aug-2014, supplier: orchid unique manufacturing site: monument: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: the complete 6mm diameter part of the reamer is broken off, the fragment was not sent back for evaluation.The cutting edges above the fracture face are badly damaged and completely blunt.In general is the device is a very used condition.There are many stress marks all over the shaft and the coupling piece on top has strong wear marks.Dimensional inspection: not required as the cause of the breakage is use related.Drawing/specification review: not required as the cause of the breakage is use related.Material or hardness review: not required as the cause of the breakage is use related.Summary: the complaint is confirmed as the reamer is broken as complained.The review of the manufacturing documents did show no complaint related issues.This lot of 41 pieces was manufactured in august 2014 and we are not aware of any other complaint for this article- and lot combination.These findings speak against a manufacturing related issue.The visual inspection has shown that the cutting edges of the reamer are badly damaged and that the reamer is completely blunt due to these damages.This indicates that a mechanical overload either by an inappropriate excessive metallic contact, e.G.With the nail, or the use of a previously damaged and blunt reamer caused the breakage.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: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7504761
• Report Number: 8030965-2018-53695
• Device Sequence Number: 1813732
• Product Code: HTO
• UDI-Device Identifier: 07611819737709
• UDI-Public: (01)07611819737709
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2018

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: 357.403
• Device Lot Number: U212263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 06/08/2018; 06/28/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/04/2018; 06/18/2018; 07/05/2018
• 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