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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD ROD,FIXATION,INTRAMEDULLARY

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SYNTHES GMBH SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.013.046
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. A device history record (dhr) review was conducted: part number: 04. 013. 046, lot number: 11l1938, part manufacture date: jul 01, 2019, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of spiral blade f/expert rfn l70 tan gold product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. 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. A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. Device history review: 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. 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) spiral blade f/expert rfn l70 tan gold. This is report 5 of 6 for (b)(4).
 
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Brand NameSPIRAL BLADE F/EXPERT RFN L70 TAN GOLD
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10876985
MDR Text Key217437261
Report Number8030965-2020-09119
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K033618
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 Number04.013.046
Device Catalogue Number04.013.046
Device Lot Number11L1938
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 Manufactured07/01/2019
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
Treatment
EXPERT END CAP F/HAN TAN GOLD; EXPERT HAN Ø10 LE CANN L240 TAN LIGHT GR; LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L66 F/NAILS TAN LIGHT GREEN
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