• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT REAMER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Fitting Problem
Event Date 02/21/2017
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Additional narrative: patient information is not available for reporting. Device is an instrument and is not implanted/explanted. The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history record review was performed for the subject device lot number. Manufacturing location: synthes (b)(4). Date of manufacture: apr 6, 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that during a reaming procedure the synream shaft did not couple tightly with the reamer heads and the heads detached during reaming. It was reported that the synream shaft coupling mechanism did not lock to the heads as intended. There were no other devices implicated. None of the device broke. The procedure was successfully completed without delay. There was no additional medical intervention required and no patient harm. The patient¿s outcome/surgical outcome was desirable. Concomitant parts reported: 1x unk reamer head, part unk, lot unk quantity 1. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Additional narrative: recall #: 3008812560-10/31/2016-015-r. A manufacturing evaluation was completed: the device shows slight abrasion and strong deformation on the closure mechanism visible. A device history record review was performed for the affected lots, of the end products and also for the component; no abnormalities or deviations were detected, which could lead to the complaint failure. The hardness of the component and the function of the device were measured and fulfill the specification (but this tested feature is not relevant to the complaint condition). The relevant dimensions for the closure mechanism cannot measured because strong deformations. It was found that the used raw material fulfilled the specifications. Based on this the complaint is rated as confirmed, since the closure mechanism shows strong deformations and is rated as reason for not properly coupling. No manufacturing related issue was identified and/or confirmed. 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.

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. Upon visual inspection, the sw5 f10 shows slight abrasion and strong deformation on the closure mechanism visible. The laser marking was readable. The product was returned in a packaging different from the original packaging. The lots of the raw material of component 507550 are not tracked by number. Therefore, the check was done based on fifo (first in/first out) by investigation of the raw material orders, which were closest to the start of the manufacturing order of the component. It was found that the used raw material fulfilled the specifications. We are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place. To prevent such problems, it is necessary to operate according to the technique guide. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
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 Key6408090
Report Number9612488-2017-10116
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number9888477
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/06/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/15/2017 Patient Sequence Number: 1
Treatment
UNKNOWN REAMER HEADS, QUANTITY UNKNOWN.
-
-