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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 7X45MM; SCREW, CORTICAL FIX, POLYAXIAL
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MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 7X45MM; SCREW, CORTICAL FIX, POLYAXIAL Back to Search Results
Model Number 186731745
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(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 synthes reports an event in (b)(6) as follows: it was reported that this was a psf (posterior spinal fusion) in l3-iliac fixation treating l5 burst fracture with viper system on aug.15, 2019.The procedure was completed without surgical delay.As an outpatient she came to see the surgeon on (b)(6) 2019.It was found that the setscrews had come off and caused a rod to be off the correct position.The patient will undergo a revision procedure on (b)(6) 2019.No further information is available.This report is for one (1) 5.5 ti cort fix 7x45mm.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1).This is report 6 of 6 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).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.A review of the device history record.Device history lot dhr of product code 186731745, lot 226193, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2018.Qty.149.The dhr was electronically reviewed.H3, h6: investigation summary background: it was reported that this was a psf (posterior spinal fusion) in l3-iliac fixation treating l5 burst fracture with viper system on aug.15, 2019.The procedure was completed without surgical delay.As an outpatient s/he came to see the surgeon on (b)(6) 2019.It was found that the set screws (unk) had come off and caused a rod to be off the correct position.The patient will undergo a revision procedure on (b)(6) 2019.No further information is available.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1).This complaint involves four (4) devices.Investigation flow: device interaction/functional visual inspection: the 5.5 ti cort fix 7x45mm (p/n: 186731745, lot #: 226193) was returned and received at us cq.Upon visual inspection, it was observed that the head of the device was stuck.There were scratches and discoloration on the device but has no impact on the functionality of the device.No other issues were observed with the returned device.Functional test: the functional test was performed on the returned device.The four returned mis single inner screws were used to assemble with the returned 5.5 ti cortx fix 7 x 45 mm device.All the four inner screws were able to assemble to the device with no defects identified.Upon assembly, the inner screw was observed to be loose, which could have caused the backed out complaint condition.The inner screws are being investigated in the other pi's in the same complaint.Dimensional inspection: the dimensional analysis was performed on the returned device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Yes, the device received was stripped.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the 5.5 ti cort fix 7x45mm (p/n: 186731745, lot #: 226193).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
Product complaint # (b)(4).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.Manufacture date provided for reporting.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
5.5 TI CORT FIX 7X45MM
Type of Device
SCREW, CORTICAL FIX, POLYAXIAL
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9601364
MDR Text Key189468875
Report Number1526439-2020-00399
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034352015
UDI-Public(01)10705034352015
Combination Product (y/n)N
PMA/PMN Number
K160904
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 12/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number186731745
Device Catalogue Number186731745
Device Lot Number226193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Date Manufacturer Received02/13/2020
Patient Sequence Number1
Treatment
UNKNOWN RODS
Patient Outcome(s) Required Intervention;
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