MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)

Catalog Number	309.068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records has been requested.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, during decontamination, a spare reamer tube for hollow reamer and an extraction bolt were found to be broken.There was no patient involvement.This complaint involves two (2) devices.This report is for one (1) spare reamer tube.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Visual inspection: the visual inspection has shown that one cutting tooth at the forefront is broken off.The broken piece was not sent back.The cutting edges of the remaining teeth are worn.Summary: there was no information provided how or when the reamer broke or if a power tool was used, this makes it impossible to determine an exact root cause.We can only assume that an excessive contact between the reamer and a screw, for example by too much lateral stress during the removal of a screw, caused a mechanical overload and finally the breakage.In general, we would like to point out following statement from page 31 in the extraction screw set handling technique (art.036.000.918: important: the hollow reamer and the extraction bolt are left-turning (to be turned anticlockwise).During insertion ensure that enough axial pressure is exerted and maintain the axis.Only use instruments with sharp edges.It is possible to use the hollow reamer with power tools, but this should be done very carefully.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.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 history lot part: 36598 (309.068) lot: 9430163 manufacturing site: (b)(4) release to warehouse date: 17.June 2015 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8384072
• Report Number: 8030965-2019-61674
• Device Sequence Number: 14010182
• Product Code: HTO
• UDI-Device Identifier: 07611819201873
• UDI-Public: (01)07611819201873
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 309.068
• Device Lot Number: 9430163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/02/2019
• Patient Sequence Number: 1