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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA-II Ø9 LONG R 130° L320 TAN ROD, FIXATION, INTRAMEDULLARY

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SYNTHES BETTLACH PFNA-II Ø9 LONG R 130° L320 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 473.065S
Device Problem Failure to Align (2522)
Patient Problem Sedation (2368)
Event Date 12/16/2015
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc. Device was not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. Manufacturing location: (b)(4). Manufacturing date: november 09, 2012. Expiry date: november 01, 2022. No non-conformance reports were generated during production that would contribute to the complaint condition. The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition. 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported there was a surgery for femoral trochanteric fracture was held on (b)(6) 2015. Both the nail and blade were applied during the surgery. After inserting the reported nail, the surgeon was only able to insert the guide wire forward or backward from the correct position; the position was confirmed with the image intensifier. Since the surgeon thought the issue might be due to loosen device, the reported nail was removed. The looseness was checked by performing the simulation; however, no issue was found. Then the surgeon inserted the nail and the guide wire into the femur; the surgeon tried to insert the reported blade from the incorrect position. Then it was found that the blade slightly interfered with the reported nail. Therefore, it was checked by using the image intensifier and it revealed that the blade had been beyond correct position forward. During removal it was found the tip of the blade was crushed. Furthermore, it was found that the hole for the blade in the reported nail was hollowed. Eventually, different sized blade and nail were replaced after treating soft tissue. And then, the surgical operation was completed. The surgical delay was sixty (60) minutes. This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. The subject device has been received and is currently in the evaluation process. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Manufacturing investigation summary: the nail shows strong surface damages in the region of the citrus hole. Furthermore, the status of the nail is good. All dimensions related to the complaint (position and dimension of citrus hole) were measured and shown to fulfill the specifications. The complaint is most probably due to a dimensional failure in the outer diameter of the sleeve of the blade, which leads to the fact that the blade cannot completely be inserted into the citrus hole of the nail. Therefore, the complaint is rated as confirmed. Since no failures were detected in relation to the nail, the complaint is rated as not valid from point of view of the manufacturing site. No manufacturing related issues were identified and/or confirmed. 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 NamePFNA-II Ø9 LONG R 130° L320 TAN
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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5346468
MDR Text Key35161790
Report Number9612488-2016-10008
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
Type of Report Initial,Followup,Followup
Report Date 12/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number473.065S
Device Lot Number8140348
Other Device ID NumberGTIN: 07611819883086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2012
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: 01/06/2016 Patient Sequence Number: 1
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