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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW ROD,FIXATION,INTRAMEDULLARY

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SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.026
Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 07/13/2017
Event Type  Injury  
Manufacturer Narrative
Additional patient¿s identifier reported as (b)(6). Patient¿s date of birth and weight are not available for reporting. Udi: (b)(4) lot number unknown device is an instrument and is not implanted/explanted. Complainant device is not expected to be returned for manufacturer review/investigation. (b)(4). 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
It was reported that the patient had underwent an open reduction internal fixation (orif) right hip fracture on (b)(6) 2017. Intra-operatively, the surgeon had inserted the trochanteric fixation nail advanced (tfna) nail implant. Subsequently, at the back table, the scrub technician had difficulty assembling the three (3) part blade insertion instrument system to the helical blade implant. The technician was instructed to remove the sleeve assembly from the other instruments. When the technician disassembled the instruments, it was reported that they contained contaminated tissue and blood inside. Surgeon removed the tfna nail due to the fact that there was not another tfna blade instrument system available in the operating room. However, a tfn set was available. The surgeon was able to implant the patient with a tfn nailing construct. The patient was implanted with one (1) (tfn) trochanteric fixation nail, one (1) helical blade and two (2) distal locking screws. There was a six (6) minute surgical delay. The procedure was completed successfully and patient was reported in stable condition. No additional information is available. This report is for one (1) helical blade/screw coupling screw. This is report 1 of 3 for complaint (b)(4).
 
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Brand NameHELICAL BLADE/SCREW COUPLING SCREW
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key6784203
MDR Text Key82468478
Report Number9612488-2017-10392
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
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.026
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 Received07/13/2017
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 Unkown

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
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