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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXPERT A2FN NAIL 9 R CANN L340 TAN LIGH ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH EXPERT A2FN NAIL 9 R CANN L340 TAN LIGH ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.009.248S
Device Problems Break (1069); Crack (1135)
Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2020. (b)(4). The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 on (b)(6) 2020, the patient underwent the implant surgery with the nail in question. One (1) month after the surgery, the patient was non-weight bearing and two (2) weeks after, she had partial weight bearing and was followed up. When the patient rehabilitated, there was metallic sound. The surgeon thought that it was possible that a screw was broken, but the x-rays were not taken because the patient was not experiencing any pain. After that, the patient reported pain, and the surgeon confirmed that the nail had been broken and malunion occurred. On august 28, 2020, the patient underwent the revision surgery. In the revision, the surgeon had difficulty in removing the broken nail. The surgeon extended the incision to remove it, and the revision surgery was completed successfully by implanting another nail with one (1) hour surgical delay. The surgeon commented that the fixation strength might be weak because the nail was thin. The patient might be overloading at her daily life during non-weight and partial bearing. No further information is available. Concomitant device reported: unknown hip screw (part # unknown, lot # unknown, quantity # unknown), unknown locking screw (part # unknown, lot # unknown, quantity # unknown, unknown end cap for a2fn (part # unknown, lot # unknown, quantity # 1). This report is for one (1) expert a2fn nail 9 r cann l340 tan ligh. This is report 1 of 1 for (b)(4).
 
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Brand NameEXPERT A2FN NAIL 9 R CANN L340 TAN LIGH
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10569838
MDR Text Key208105192
Report Number8030965-2020-07330
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.248S
Device Lot NumberL896528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2018
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: 09/22/2020 Patient Sequence Number: 1
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