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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: S.B.M. SAS PULLUP ADJUSTABLE CORTICAL FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION
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S.B.M. SAS PULLUP ADJUSTABLE CORTICAL FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION Back to Search Results
Catalog Number PULLU01201
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
The plate remained in the patient's knee: it is on the outer side of the knee; no possible migration inside.Risk of migration into a friction zone - may require a re-intervention to remove it if it disturbs.To complete our investigation, we requested additional information: what is the date of incident? is there a clinical consequence for the patient? did the surgeon indicate that the incident caused or contributed to serious injury? was the surgical technique strictly followed? how did the device malfunction? which braid was broken? (braid with blue stripe? white braid? or green braid?) are there any contributing factors related to the event? if yes, could you explain please? could you confirm the lot number? (200016 in your email, 200012 on the labels transmitted) the pullup device was not explanted: is that correct? did the braids are available for expertise? if yes, could you return it to my attention? did a delay in the procedure over 30 minutes occur that was related to the event? if yes, how long of a delay? patient information (age - weight): did the health care facility declare this incident to the national competent authority? ·.
 
Event Description
(b)(4).Incident occured in (b)(6) transmitted by our distributor.Date of event is unknown."we carried out an intervention in bologna in the cdc nigrisoli clinic with dr.(b)(6).The patient was a very large young male boy.I was told that the surgery went well.The tibial tunnel was probably a little more posterior than usual.The ligament was a diameter 9 and was fixed at the level of the femur with a pullup and in the tibia with an 11 x 30 ligafix screw.After tibial fixation (which according to the specialist was done with the knee at 90-100 °) arthroscopic control was performed and the ligament was stable.Subsequently, after some knee movements the doctor heard a strange noise.Another check was made and it was found that the ligament was no longer stable.The screw has been removed and the lca has come down.It was subsequently re-fixed at the femoral level with a btb xl pullup and at the tibial level with the same 11x30 ligafix screw with the knee more flexed"."the pulup is lot: 200016, unfortunately i don't have pictures, the thread at the base of the plate had broken.The plate remained at the end of the femur.It has not been removed »".
 
Manufacturer Narrative
The plate remained in the patient's knee: it is on the outer side of the knee; no possible migration inside.Risk of migration into a friction zone - may require a re-intervention to remove it if it disturbs.To complete our investigation, we requested additional information: what is the date of incident? is there a clinical consequence for the patient? did the surgeon indicate that the incident caused or contributed to serious injury? was the surgical technique strictly followed? how did the device malfunction? which braid was broken? (braid with blue stripe? white braid? or green braid?) are there any contributing factors related to the event? if yes, could you explain please? could you confirm the lot number? (200016 in your email - 200012 on the labels transmitted) the pullup device was not explanted: is that correct? did the braids are available for expertise? if yes, could you return it to my attention? did a delay in the procedure over 30 minutes occur that was related to the event? if yes, how long of a delay? patient information (age - weight): did the health care facility declare this incident to the national competent authority? follow-up 1: additional information requested: what is the date of incident? (b)(6) 2020.Is there a clinical consequence for the patient? no.Did the surgeon indicate that the incident caused or contributed to serious injury? no.Was the surgical technique strictly followed? yes.How did the device malfunction? which braid was broken? (braid with blue stripe? white braid? or green braid?) white.Are there any contributing factors related to the event? no.Could you confirm the lot number? (200016 in your email below - 200012 on the labels / attached file) pullu01201 - lot: 200012.The pullup device was not explanted: is that correct? was explanted.Then implanted a new one pulp xl.Did the braids are available for expertise? no.Did a delay in the procedure over 30 minutes occur that was related to the event? more or less.Time to prepare the ligament again with the new pullup.20 - 30 min maximum.Patient information (age - weight): i do not know.Did the health care facility declare this incident to the national competent authority? no.Result of investigations (analysis of data manufacturing): the device was not returned and no photo was available.Data regarding manufacturing and packaging attest to the good progress of the manufacture of the medical device.The mechanical performance tests in traction carried out on the braid of the above-mentioned batch comply with our specifications.The constituent components of the pullup comply with our specifications.Several hypotheses can be made as to the origin of the pullup braid rupture when extending the patient's leg: 1st hypothesis: the breakage of the pullup braid results from the presence of a sharp edge on one of the contact points of the braid.The stress put on the braid in tension in contact with this edge caused the cutting of the multifilaments of the braid in contact, causing it to break.This hypothesis is plausible but unlikely due to the numerous controls put in place to detect this type of fault.Because the button-plate was not available, we could not perform a metrological expertise.Hypothesis 2: while suturing the graft, one of the white braids was damaged by the needle.We have assessed this scenario which generates a loss in tensile strength of the pullup system of more than 50%, with a resistance level of 400n.3rd hypothesis: after implantation of pullup in the femur, too much traction was exerted on the graft during insertion of the tibial screw, then during cycling of the knee.This caused white braid to give way.Because the button-plate and the braid were not available to determine the origin of the rupture mechanism, a definitive conclusion cannot be drawn.No corrective action.
 
Event Description
(b)(4).Incident occured in italy - transmitted by our distributor.Date of event is unknown."we carried out an intervention in bologna in the (b)(6) clinic with dr.(b)(6).The patient was a very large young male boy.I was told that the surgery went well.The tibial tunnel was probably a little more posterior than usual.The ligament was a diameter 9 and was fixed at the level of the femur with a pullup and in the tibia with an 11 x 30 ligafix screw.After tibial fixation (which according to the specialist was done with the knee at 90-100 °) arthroscopic control was performed and the ligament was stable.Subsequently, after some knee movements the doctor heard a strange noise.Another check was made and it was found that the ligament was no longer stable.The screw has been removed and the lca has come down.It was subsequently re-fixed at the femoral level with a btb xl pullup and at the tibial level with the same 11x30 ligafix screw with the knee more flexed"."the pulup is lot: 200016 - unfortuntely i don't have pictures - the thread at the base of the plate had broken.The plate remained at the end of the femur.It has not been removed ".
 
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Brand Name
PULLUP ADJUSTABLE CORTICAL FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION
Type of Device
ADJUSTABLE CORTICAL FIXATION SYSTEM
Manufacturer (Section D)
S.B.M. SAS
zi du monge
lourdes, france 65100
FR  65100
MDR Report Key11046040
MDR Text Key222703038
Report Number3004549189-2020-00024
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K151004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPULLU01201
Device Lot Number200012
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received11/23/2020
Supplement Dates FDA Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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