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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA Ø12 LONG LE 125° L380 TAN; ROD, FIXATION, INTRAMEDULLARY

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SYNTHES BETTLACH PFNA Ø12 LONG LE 125° L380 TAN; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.249S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient id, date of birth and weight are not available for reporting.(b)(4).(b)(6).(b)(4).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.Device records review was completed for part # 04.027.249s, lot # 9943331.Manufacturing site: (b)(4), manufacturing date: may 18, 2016, expiry date: may 01, 2026.No non conformance reports were generated during production.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.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.
 
Event Description
Device report for synthes europe reports an event in (b)(6) as follow: it was reported that second (2nd) revision surgery was scheduled to be performed on (b)(6) 2016, due to breakage of proximal femoral nail-antirotation (pfna) nail.The patient initially had the pfna system implanted on an unknown date approximately two (2) months prior to the first (1st) revision surgery to treat a sub trochanteric fracture.Two months (date also unknown) later patient has presented with the nail broken at the point where the blade crosses through.The surgeon acknowledged that there was quite a large bone void which was left.During the revision surgery on (b)(6) 2016, the original nail was removed and the patient was revised with another pfna nail.First revision surgery is capture under (b)(4).This report is for one (1) pfna nail.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that: we have forwarded the received nail (04.027.249s / 9943331) to the responsible manufacturing site for investigation, here is the statement: upon visual inspection, the product was returned in a packaging different from the original packaging.The laser marking was readable.The nail was cross broken in the position of the citrus hole.Traces of use were visible around the citrus hole.Slightly traces of use were visible on the other part of the nail.A device history record (dhr) review was performed for the affected lot, (b)(4) parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in may 2016.No ncrs were marked in the dhr during production.Moreover a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.The outer diameter which is relevant for the function of the product was measured, and fulfills the specifications.Citrus hole could not be measured in reason of breakage.The according inspection sheet shows a 100% approval of the dimension of the citrus hole.The raw material certificates were checked and it was found that all used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed, but not valid from the point of view of the manufacturing site.No manufacturing related issue was identified and/or confirmed.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence.Furthermore, we have also received two intact parts (1x blade 04.027.035s / l021208 and 1x screw 459.500 / 5935376): as those parts are not responsible for the breakage of the nail, no further investigation will be done.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.
 
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Brand Name
PFNA Ø12 LONG LE 125° L380 TAN
Type of Device
ROD, 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 Key6099105
MDR Text Key59745268
Report Number9612488-2016-10459
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number04.027.249S
Device Lot Number9943331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/22/2016
Initial Date FDA Received11/14/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2016
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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