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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. (b)(4). 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 an unknown date, that the patient¿s nail broke post-op. On (b)(6) 2020, the patient underwent the implant surgery with the nail. One (1) month after the surgery, the patient had 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 did not feel any pain. After that, the patient reported pain, and the surgeon confirmed that the nail had been broken and malunion occurred. On (b)(6) 2020 the patient underwent the revision surgery. In the revision with the full anesthesia, the surgeon had difficulty in removing the broken nail. The surgeon extended the incision to remove it, and the revision surgery was completed successfully implanting another nail with a one (1) hour surgical delay. The scheduled revision surgery time was four (4) hours. 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. Concomitant device reported: hip screw (part number unknown, lot unknown, quantity unknown), locking screw (part number unknown, lot unknown, quantity unknown), end cap for a2fn (part number unknown, lot unknown, quantity 1). This product complaint, (b)(4), is related to (b)(4). (b)(4) was created to capture the intra-operative event of the device removal and the surgeon having difficulty in removing the broken nail. (b)(4) captured post-operative event. This report involves one (1) expert a2fn nail ø9 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 Key10568053
MDR Text Key208116186
Report Number8030965-2020-07305
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? No
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? No
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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