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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 110MM STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES ELMIRA TFNA HELICAL BLADE 110MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.310S
Device Problems Off-Label Use (1494); Device Handling Problem (3265)
Patient Problem No Code Available (3191)
Event Date 07/16/2017
Event Type  Injury  
Manufacturer Narrative
Additional patient identifier reported as (b)(4). Added lot number for the concomitant device. Explant date: not explanted. 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
Concomitant devices reported: helical blade inserter (part # 03. 037. 024, lot # t145483, quantity # 1).
 
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient weight not provided for reporting. Other udi: (b)(4). Device is not expected to be returned for manufacturer review/investigation. The complainant reported that the helical blade inserter was not lined up with blade screw guide as instructed in the technique guide. Instead the surgeon hammered the helical blade inserter into grooves in the blade / screw guide and the grooves were malformed. As a result, helical blade got stuck inside screw guide. This resulted in the surgeon having to insert the blade without the blade screw guide. The blade was inserted too far and required additional surgical intervention. This will be reported as a serious injury and product malfunction, caused by use error. Device history records review was conducted. The report indicates that: dhr review for part # 04. 038. 310s lot # 9888507, release to warehouse date: 12 october 2015, expiration date: 31 august 2025, manufacturing site: (b)(4). Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of tfna helical blade 110mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture 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 initial tfn-a surgery on (b)(6) 2017, helical blade inserter was not lined up with blade / screw guide instead surgeon hammered the helical blade inserter into grooves in the blade / screw guide and the grooves were malformed. As a result, helical blade got stuck inside screw guide. There is no allegation against helical blade inserter and helical blade. Surgeon was able to remove the helical blade and re-inserted the same helical blade without the blade guide. Procedure was completed successfully. There was surgical delay for unknown time period. Intra operative x-rays were taken during initial surgery (not available for review) and surgeon thought that helical blade was inserted okay and he closed the patient and completed the surgery. Post-operatively, x-rays taken on (b)(6) 2017, determined that the surgeon inserted the helical blade too far into the femoral head and has planned revision surgery for (b)(6) 2017 to back out the helical blade a few millimeters. Surgeon backed out the helical blade a few millimeters on (b)(6) 2017. The revision surgery was successful with no delay in procedure and patient is reported as stable post operatively. This complaint involves two devices (blade/screw guide sleeve and helical blade). Concomitant devices reported: helical blade inserter (part # 03. 037. 024, lot # unknown, quantity # 1). This report is 2 of 2 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 110MM STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6755821
MDR Text Key246577287
Report Number3003506883-2017-10146
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.310S
Device Lot Number9888507
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/31/2017 Patient Sequence Number: 1
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