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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH EXPERT HAN 10 LE CANN L240 TAN LIGHT GR ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH EXPERT HAN 10 LE CANN L240 TAN LIGHT GR ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.008.078S
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. Initial 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. A device history record (dhr) review was conducted: part: 04. 008. 078s, lot: 2l96112, manufacturing site: (b)(4), release to warehouse date: jan 12, 2019, expiry date: jan 01, 2029. Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 04. 008. 078, lot number: h756978, manufacturing site: (b)(4), release to warehouse date: dec 06, 2018. Manufacturing location: (b)(4), manufacturing date: oct 18, 2018, part number: 04. 008. 078, 10mm ti hindfoot arthrodesis cann nail ex 240mm/left, lot number: h756978 (non-sterile), lot quantity: (b)(4). Work order traveler met all inspection acceptance criteria. Inspection sheet, in-process / inspect dimensional / final, ns072585 met all inspection acceptance criteria. Packaging label log (pll) lmd was reviewed and determined to be conforming. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component part(s) reviewed: part number: 21012, tialnbri13. 00, lot number: h701863, lot quantity: (b)(4). Certified test report supplied by (b)(4) dated jul 30, 2018 was reviewed and determined to be conforming. Lot summary report dated aug 02, 2018 met all inspection acceptance criteria. Raw material receiving/putaway checklist met all inspection acceptance criteria. Device history review: nov 05, 2020: dhr reviewed. 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 han 10 le cann l240 tan light gr. This is report 2 of 6 for (b)(4).
 
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Brand NameEXPERT HAN 10 LE CANN L240 TAN LIGHT GR
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10876960
MDR Text Key217682466
Report Number8030965-2020-09115
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 Number04.008.078S
Device Catalogue Number04.008.078S
Device Lot Number2L96112
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 Manufactured01/12/2019
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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