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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE
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MEDOS INTERNATIONAL SàRL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Model Number 228151
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).The lot number is unknown.
 
Event Description
It was reported by affiliate via complaint submission tool that during an unknown procedure the when doing the first fire the trigger of the truespan 12 degree peek made a click and the trigger was loose and broken.With the second truespan 12 degree peek the implant came out without pressing the trigger.No patient consequence and no surgical delay was reported.No additional information was provided.
 
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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
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.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.Investigation summary: the complaint device was received and evaluated.Visual observation reveals that one of the implant was in released conditioned (still attached to the suture).The functional testing was checked, trigger was working intended as second implant was able to be fired/released upon squeezing trigger.Since the device was received with an implant in deployed condition, the complaint can be confirmed for pre-fired.However, we cannot discern any definite root cause based on the provided information.No structural anomalies were observed.A mre was reviewed, no non-conformances were identified for the reported part 228151- lot 5l80082 number combination.At this point, 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.Udi: (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: d4: the lot number was documented as unknown on the initial report and has been updated as 5l80082.Therefore, udi: (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that it was unknown if there was a surgical delay.It was reported that it was unknown if there were any patient consequences or impact to the user/patient.It was reported that it was unknown if the case was completed.It was reported that an alternative product was readily available.It was reported that it was unknown if there was any surgical intervention planned.It was reported that the event date was unknown.It was reported that the lot number on the device used was unknown.
 
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Brand Name
TRUESPAN 12 DEGREE PEEK
Type of Device
SOFT-TISSUE ANCHOR, BIOABSORBABLE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9466029
MDR Text Key204924195
Report Number1221934-2019-59956
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,Followup,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model Number228151
Device Catalogue Number228151
Device Lot Number5L80082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2019
Date Manufacturer Received02/21/2020
Patient Sequence Number1
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