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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH EXPERT END CAP F/HAN TAN GOLD ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH EXPERT END CAP F/HAN TAN GOLD ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.008.000S
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is jnj representative. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device history lot. Sterile part: part: 04. 008. 000s, lot: 6l33688, manufacturing site: (b)(4), supplier: früh verpackungstechnik ag, release to warehouse date: oct. 18, 2019, expiry date: oct. 01, 2029. Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed. Non-sterile part: part # 04. 008. 000, synthes lot # 10l1314, supplier lot # 10l1314, supplier: jabil inc. -(b)(4), release to warehouse date: sep 19, 2019. Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent revision surgery around 9pm to reposition the expert han nail, expert end cap, spiral blade, and three (3) locking screws. The original procedure was completed on (b)(6) 2020 in the afternoon. The surgeon originally placed the expert han nail but diagnostic imaging showed evidence that the expert han nail remained extramedullary in the mid-distal third of the tibia. This required revision surgery to carry out repositioning of the implants. There was patient consequence. This complaint involves six (6) devices. This report is for (1) expert end cap f/han tan gold. This is report 1 of 6 for (b)(4).
 
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Brand NameEXPERT END CAP F/HAN TAN GOLD
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10877042
MDR Text Key217691555
Report Number8030965-2020-09112
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K051678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.008.000S
Device Catalogue Number04.008.000S
Device Lot Number6L33688
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2019
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: 11/20/2020 Patient Sequence Number: 1
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