MAUDE Adverse Event Report: SYNTHES BETTLACH SPARE REAMER TUBE FOR HOLLOW REAMER (309.450)

Catalog Number	309.480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review was performed for the subject device lot number 9828843.This lot indicates component 5787 which is part of the complete part as described in the complaint.Manufacturing location: (b)(6).Date of manufacture: 19.Apr.2016.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 spare reamer tube for hollow reamer broke intra operatively during an unknown procedure on (b)(6) 2017.Reportedly a portion of the device snapped off.Procedure completed successfully with no harm to the patient.It is unknown if there were any surgical delays or if fragments were generated from the broken device.There was no additional medical intervention required and no unanticipated x-rays taken due to the intraoperative event.There is no additional information available about the patient and reportedly, all available information has been submitted as the reporter was not present during the procedure.The broken device will be returned for investigation.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The initial complaint was reviewed and found not reportable.It was determined that this complaint (com-(b)(4) is a duplicate report of com-(b)(4).It was decided that the com-(b)(4) will be the document of record for 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
Mw-469949 report was initially submitted on october 27, 2017 but the fda site was down.Advised by fda on november 06, 2017 to resubmit medwatch.Device 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 (309.450)
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 7003005
• Report Number: 9612488-2017-10541
• Device Sequence Number: 13791427
• Product Code: HTO
• UDI-Device Identifier: 10886982185754
• UDI-Public: (01)10886982185754(10)9828843
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2017

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: 309.480
• Device Lot Number: 9828843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/06/2017; 11/14/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 11/07/2017; 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1