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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY
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SYNTHES GMBH TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.205S
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
Date of evet: event year is reported as 2020; however exact date of event is unknown.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.(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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient was treated with a tfna set.After the procedure, it was notice that the femoral neck component moved out laterally even though it was locked statically.The patient condition was unknown.Concomitant device reported: tfna end cap (part # 04.038.000s, lot # 50p9709, quantity 1), locking screw (part # 04.005.524, lot # 33p8476, quantity 1).This complaint involves two (2) devices.This report is for (1) tfna fenestrated screw 105mm - sterile.(b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6 product was not returned and therefore, no further investigation is possible.Reviewing attached x-rays, the complaint condition that the femoral neck screws backed out from the nail could be confirmed.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot : device history review done by gabrielle truong on 05 november 2020.Part number: 04.038.205s, lot number: h798081, part manufacture date: 16 january 2019 , manufacturing location: elmira, part expiration date: 01 january 2029, 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 tfna fenestrated screw was reworked ¿ ultrasonic clean to improve part appearance due to an uneven surface finish.The rework only affects cosmetics, which was inspected 100% at a downstream inspection operation and has no affect on the complaint condition.The lot quantity of 48 pieces 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 device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch : null.Device history review : the lot pieces 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.
 
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Brand Name
TFNA FENESTRATED SCREW 105MM - STERILE
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10855882
MDR Text Key216962065
Report Number8030965-2020-08999
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.038.205S
Device Lot NumberH798081
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received11/18/2020
12/15/2020
12/22/2020
Supplement Dates FDA Received11/20/2020
12/18/2020
12/23/2020
Patient Sequence Number1
Treatment
LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN
Patient Outcome(s) Required Intervention;
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