MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228151

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by the affiliate via complaint submission tool, that during a meniscal repair, the surgeon pressed the red trigger on the truespan 12 degree peek but it was jammed.It was reported the trigger was hard and not easy as usual, when the surgeon depressed the trigger for the first and second implant.It was stated implants did not hold and a surgical delay of unknown time occurred.The affiliate reported the procedure was completed with another truespan device that was readily available.The affiliate reported surgical intervention is not planned and no patient harm was reported.

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.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

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: investigation summary
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> the complaint device was received and inspected.A visual inspection was conducted to determine if the device had any gross visual defects that may contribute to the reported failure.The red trigger is loose and doesn't function as intended.The distal tip of the needle is deformed.The sleeve was removed to inspect the configuration of the implants per the drawing.From this it was verified that the implants were both missing from the intended configuration which signifies that they had been deployed.With the information provided we cannot determine a definitive root cause.However, one possible root cause can be attributed to user mishandling of the device causing the device not to function as intended.Furthermore, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [3l68982] number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9444205
• MDR Text Key: 207003843
• Report Number: 1221934-2019-59915
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

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 Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 3L68982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/11/2019; 01/29/2020
• Supplement Dates FDA Received: 12/23/2019; 01/30/2020
• Patient Sequence Number: 1