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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE
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MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Model Number 228151
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the affiliate in (b)(6) that during a knee arthroscopy and meniscus repair procedure on (b)(6) 2020, it was observed that the pistol hand grip on the truespan meniscal repair system peek 12 degree device seem to be broken that the device did not work; and that it was out of order every time.Another like device was used to complete the procedure with a delay of five to ten minutes.There were no adverse patient consequences reported.No additional information was provided.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that during an knee arthroscopy and meniscus repair ten truespan meniscal repair system peek 12 degree did not work, the system was out of order every time, all 10 pistol hand grips seem to be broken.The complaint device was received and evaluated; visual inspection reveals that there are no anomalies or structural damage on the outside of the device.The stop tube was cut to confirm the presence of both implants; however, they could not be found, which is a sign that they were deployed.The functional test of the red trigger was performed several times, no stuck or damages could be identified.Due to the both implants were found to be deployed, this complaint can be confirmed.A possible root cause can be attributed to the handling of the device, the operator probably did not introduce the needle to the appropriate depth resulting in a non desired deployment, then a second try ended with both plates deployed, however this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device [6l60683] number, and no non-conformances were identified.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
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Brand Name
TRUESPAN 12 DEGREE PEEK
Type of Device
SOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ  CH-2400
MDR Report Key10878250
MDR Text Key217724105
Report Number1221934-2020-03547
Device Sequence Number1
Product Code MBI
UDI-Device Identifier10886705026012
UDI-Public10886705026012
Combination Product (y/n)N
PMA/PMN Number
K153667
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 11/06/2020
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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Model Number228151
Device Catalogue Number228151
Device Lot Number6L60683
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Date Manufacturer Received12/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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