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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RTI SURGICAL 1.7MM CABLE WITH CRIMP 750MM; CERCLAGE FIXATION
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RTI SURGICAL 1.7MM CABLE WITH CRIMP 750MM; CERCLAGE FIXATION Back to Search Results
Catalog Number 298.801.01
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510k: this report is for an unknown 1.7mm cerclage cable/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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 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 the patient's subtrochanteric fracture was initially treated with competitor's femur nail, but due to the fracture and the posterior position of the cephalic screw, the material was changed.To help close the fracture site, and reinforce the bone loss caused by the removed material, surgeon placed 3.5 mm cortical screws in the part of the femoral neck.In addition, surgeon reinforced the osteosynthesis of the subtrochanteric fracture with a 3.5mm locking compression (lcp) 6 holes plate.Another pair of 3.5 mm screws was placed to position a fibula bone graft in the lateral cortex due to a significant loss of this part and to help, surgeon placed two (2) 1.7 mm cerclage cables.However, surgeon had to remove one of the cerclage cables because it was not properly positioned and, furthermore, he could not remove it completely and proceeded to place another and fix it to the previously mentioned lcp plate with a positioning pin for 3.5mm lcp.Once this initial part was made, a ø10 130º right tfna l340 nail was placed, fixed with a tfna perf l 105 spiral blade and two (2) 0.5mm locking screws of 36 and 44 mm.To reinforce the spiral blade in the head of the femur, an augmentation was made with 2 doses of traumacem v + previously verified with contrast medium, thus confirming that there is no intra-articular leakage towards the hip.No further information reported.Concomitant device reported: unknown lcp plate (part#: unknown, lot#: unknown, quantity: 1); unknown 3.5 cortex screws (part # unknown, lot # unknown, quantity # 2); unknown 1.7 mm cerclage cable (part # unknown, lot # unknown, quantity # 1).This report is for one (1) unknown 1.7mm cerclage cable.This is report 1 of 1 for complaint (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.H11: corrected data: b4/g3: awareness date originally reported as september 04, 2020 but should have been september 03, 2020.
 
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, h6: investigation summary product was not returned.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 part # 298.801.01, synthes lot # p345716, supplier lot # p345716, release to warehouse date: oct 14, 2019, supplier: (b)(4), no ncr's were generated during production.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
Updated event description: it was reported that the cerclage cable could not be removed completely.Concomitant device reported: unknown lcp plate (part#: unknown, lot#: unknown, quantity: 1); unknown 3.5 cortex screws (part # unknown, lot # unknown, quantity # 2); 1.7 mm cerclage cable (part # 298.801.01, lot # p345716 , quantity # 1).This report is for (1) 1.7mm cable with crimp 750mm.This complaint involves one (1) device.
 
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Brand Name
1.7MM CABLE WITH CRIMP 750MM
Type of Device
CERCLAGE FIXATION
Manufacturer (Section D)
RTI SURGICAL
375 river park circle
marquette MI 49855
MDR Report Key10603219
MDR Text Key209243951
Report Number8030965-2020-07526
Device Sequence Number1
Product Code JDQ
Combination Product (y/n)N
PMA/PMN Number
K992616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number298.801.01
Device Lot NumberP345716
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2020
Patient Sequence Number1
Treatment
CERCL-CABLE W/CRIMP Ø1.7 SST; UNK - CABLE/WIRE; UNK - PLATES; UNK - PLATES; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
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