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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L95 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.034S
Device Problems Use of Device Problem (1670); Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2019
Event Type  malfunction  
Manufacturer Narrative
Device returned. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history record: device history lot: part: 04. 027. 034s, lot: 4l75380, manufacturing site: (b)(4), release to warehouse date: 23 may 2019, expiry date: 01 may 2029. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Investigation summary: investigation site: (b)(4). Selected flow: device interaction / functional. Visual inspection: the pfna blade was returned in disassembled condition. There are slight traces of use visible, especially at the olive shaped sleeve. Otherwise is the blade in a good condition. Function test: the blade was reassembled with a hex-wrench during the investigation as defined in the assembling instruction was performed. The blade could be attached to the impactor as designed and the blade did rotate freely after attaching it to the impactor. Also it was possible to lock the blade as designed by removing the impactor. The complained malfunction of did not rotate and fell apart could not be reproduced. Summary: according to the provided information could the blade not be implanted, because it did not rotate. When separated from impactor, the blade fell apart. The complained is confirmed as the blade was returned in disassembled condition. Regarding the rotation is the complaint unconfirmed as the device is functional as required. The root cause regarding the rotation issue can not be defined as it could not be reproduced. The fell apart condition was apparently caused during disassembling by manipulation by hand as the insertion depth of the impactor is not long enough to cause a complete disassembling of the device based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected. 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 reports an event in (b)(6) as follows: it was reported that intraoperatively, the pfna blade fell apart. Another blade was available and used without issues. No patient harm reported. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NamePFNA BLADE PERF L95 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8970538
MDR Text Key156780515
Report Number8030965-2019-68044
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
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 08/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.034S
Device Lot Number4L75380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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