MAUDE Adverse Event Report: SYNTHES BETTLACH HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS

Catalog Number 309.450

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.(b)(4).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.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 Description

This report is for a veterinary case.There was no human patient involvement.It was reported that during a veterinary procedure on (b)(6) 2017 for the removal of a 4.5 mm screw shaft that was retained after intraoperative breakage of the screw during the initial hardware removal attempt on (b)(6) 2017 (please see related com-(b)(4)).A reamer tool was required to remove the remaining screw shaft.As surgeon was preparing to remove the screw shaft on (b)(6) 2017, he began reaming manually and without the use of power.The surgeon was unable to get purchase on the bone and tried pushing on the hollow reamer to get it to bite, which caused four (4) of the six (6) instrument teeth to break off.All broken teeth were easily recovered.The surgeon commented that the remodeled bone was very dense, causing difficulty during reaming.The surgeon continued the procedure and successfully removed the screw shaft.The equine patient was not revised with any additional hardware.There was no surgical delay.Preoperative x-rays were taken on (b)(6) 2017.The procedure was completed successfully and the equine patient outcome was reported as stable.The screw that was causing the irritation was successfully removed.The initial implant procedure was performed on an unknown date approximately five (5) years prior to the date of this report to treat a cannon bone (right metatarsus) fracture.Concomitant device reported: spare reamer tube for hollow reamer (part 309.480, lot number unknown, quantity 1).This report is for one (1) hollow reamer for 4.5 mm screws.

Manufacturer Narrative

Corrected data: after the manufacturing investigation of the returned device, the initially reported concomitant device spare reamer tube is no longer considered as concomitant device and is now determined as the reportable device.Complainant device is not expected to be returned for manufacturer review/investigation.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 Description

Upon receipt of the spare reamer it was identified that several of the teeth were broken off and missing.Product development engineer also confirmed that teeth from the spare reamer also broke off and were retrieved.This is report 1 of 3 for complaint (b)(4).

• Brand Name: HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6568863
• MDR Text Key: 75328851
• Report Number: 9612488-2017-10216
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1