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 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.Dhr review was completed.Lot number 9828843 indicates component 5787 which is part of the complete part as described in the complaint.Manufacturing location: (b)(4).Manufacturing date: 19.Apr.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 during unknown procedure on (b)(6) 2017 a part of the spare reamer tube for hollow reamer snapped off.No patient harm was reported.No information was provided on whether the surgery was delayed as a result of the device malfunction.The procedure was successfully completed.Patient outcome is unknown.Concomitant devices reported: hollow reamer complete for 4.5mm screws (309.450, lot number unknown, quantity 1), reamer/irrigator/aspirator (ria) tube assembly (part number unknown, lot number unknown, quantity 1) this report is for one (1) spare reamer tube for hollow reamer this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device has been received and the product evaluation is in progress.No conclusion can be drawn.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
Concomitant medical products: updated lot# to reported concomitant device hollow reamer.Product development investigation was completed.A visual inspection, dhr review, dimensional inspection, and drawing review were performed as part of this investigation.The device was returned and reported to have broken intraoperatively.This condition is confirmed; a spiral shaped chip encompassing approximately half the circumference of the distal face and extending about eleven millimeters down the shaft is missing.The device was manufactured in 4/2016 and is over a year old.The balance of the returned device is in fairly worn condition with a second crack running about nine millimeters on the opposing side of the shaft.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The outer diameter of the shaft of the device measured to specification (6.9/7.0mm) at 6.96mm.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no ncrs germane to the complaint condition were generated during the production of this device.Material and hardness were conforming at the time of manufacture.All measurements have been performed by calipers ca99p.The 309.480 spare reamer tube is an instrument routinely used in the screw removal set as per the relevant technique guide.It is likely that over a year of consistent use and possibly a collision with an implant during surgery has led to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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
Concomitant devices reported: hollow reamer complete for 4.5mm screws (part# 309.450, lot# 9167235, quantity 1).

• 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: 6978125
• Report Number: 9612488-2017-10537
• Device Sequence Number: 1352271
• 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: 10/19/2017; 11/30/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/13/2017; 12/04/2017
• Patient Sequence Number: 1