MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REAMER Ø6/10 CANN L435 NO. 511.760

Catalog Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Date of device breakage is not known.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.Initial reporter telephone and email not available for reporting.Without a lot number the device history records review could not be completed.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 reamer broke during an unknown surgical procedure on an unknown date.This report is for one (1) 6mm/10mm reamer.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Patient ethnicity is unknown.Procedure outcome added.Lot number is now known.Part: 357.403, synthes lot: u158076, supplier lot: u158076, release to warehouse date: september 10, 2012, supplier: (b)(4); no nonconformance reports (ncrs) were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.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.Investigation site: (b)(4), selected flow: 5.Broken.Visual inspection: the complete coupling piece of the reamer is broken off; the fragment was sent back for evaluation.The cutting edges of the reamer are badly damaged and completely blunt.In general, the device is in 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: checked dimensions with caliper 3-01-19789: outer diameter at the fracture face specification 5.6mm +/-0.1 / measured: 5.57mm = pass; inner diameter at the fracture face specification 3.7mm +0.2/-0.1 / measured: 3.76mm = pass.Drawing/ specification review: not required per selected investigation flow as the cause of the breakage is use related.Material or hardness review: according to the manufacturing documents, the hardness did meet specification.Summary: the complaint is confirmed as the reamer is broken as complained.The review of the manufacturing documents showed no complaint related issues.This lot of (b)(4) pieces was manufactured in september 2012 and we are not aware of any other complaint for this article and lot combination.These findings, and the overall appearance of the reamer, 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.(b)(4).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
The procedure was completed successfully with no reported delay.There was no reported patient harm.

• Brand Name: REAMER Ø6/10 CANN L435 NO. 511.760
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7594344
• Report Number: 8030965-2018-54293
• Device Sequence Number: 11206437
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 357.403
• Device Lot Number: U158076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1