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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number 228161
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
It was reported by the distributor in spain that during a meniscal suture.Surgical procedure on (b)(6) 2024 while using the truespan 12 degree plga device after the pistol carrying the implant was inserted in the meniscus the device had difficulty firing the same and was performing with a resistance that did not exist anatomically.In both cases the implant left with difficulty from the rail and once lodged was not fixed in the meniscus.It did not allow the suture to run and finally the implant had to be removed from its function and is out.It was unknown if there was a delay to the procedure or if the procedure was completed successfully.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 of the same event.
 
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the device manufacture date was unknown d10: concomitant device: truespan 12 degree plga, therapy date: (b)(6) 2024.Udi: (b)(4).
 
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device, and no non-conformance was 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.D4, h4: the expiration date and device manufacture date have been added.
 
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Brand Name
TRUESPAN 12 DEGREE PLGA
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle 02400
SZ   02400
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key18922556
MDR Text Key337884801
Report Number1221934-2024-00898
Device Sequence Number1
Product Code MBI
UDI-Device Identifier10886705026043
UDI-Public10886705026043
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K153667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number228161
Device Lot Number197L768
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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