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U.S. Department of Health and Human Services

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

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SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Fitting Problem
Event Date 08/11/2016
Event Type  Malfunction  
Manufacturer Narrative

Device used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: part# 352. 040 lot# 9947895 manufacturing location: (b)(4), manufacturing date: 13. Jun. 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that during an intramedullary nailing procedure a reamer head would not go on the flexible shaft. Another flexible shaft was readily available and used to complete the surgery, so there was no delay in surgery or patient harm. There is 1 device in this complaint. Concomitant devices reported: reamer head (part# unknown, lot# unknown, quantity 1). This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Product investigation was completed. One flexible reamer shaft (part # 352. 040, lot # 9947895) was returned for investigation. The device was reported to not be able to attach to a reamer head. This was confirmed. A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Drawings were reviewed as part of this investigation. A previous non-manufacturing investigation found that the design of the device allows for a conforming part that does not fulfill its functional requirements. A previous manufacturing investigation found that a tooling/manufacturing change resulted in this lot not fulfilling their functional requirements. The geometry is adequately defined but the possibility of a non-functional hex remains depending on the manufacturing process used. Furthermore the missing information is included in the applicable norms which are however not specified on the drawing. The drawing will be adapted to avoid wrong manufacturing processes and therefore non-functional hex (wrench) geometry. 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.

 
Manufacturer Narrative

Upon further review of this complaint, and reassessment of the attached complaint histories, it has been determined that this is a non-reportable event. There are no similar histories in the attached complaint histories which led to death or serious injury. The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur. 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 further review of this complaint, and reassessment of the attached complaint histories, it has been determined that this is a non-reportable event. There are no similar histories in the attached complaint histories which led to death or serious injury. The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.

 
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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
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5930785
Report Number9612488-2016-10363
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number9947895
OTHER Device ID Number(01)10886982194114(10)9947895
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/25/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/13/2016
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: 09/06/2016 Patient Sequence Number: 1
Treatment
REAMER HEAD (PART# UNKNOWN, LOT# UNK, QTY. 1
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