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

Model Number 228151

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a meniscal repair procedure the trigger of this truespan meniscal repair system peek 12 degree is jammed.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The same issue was reported back on (b)(6) 2019 for the same lot number, therefore 3 unopened devices will also be returned.

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: investigation summary
=
> the complaint device was received and evaluated.Visual observation reveals that both the implants of the device are in the channel of the needle inside the sleeve.The tip of the suture thread was visible in the channel of the needle outside the sleeve.There is a rattling noise from the gun as if some internal part that holds the red trigger has broken and fallen off.The red trigger of the device was loose and does not function anymore.Functional testing of the received device cannot be performed due to the broken handle.Thus, the reported complaint cannot be confirmed.Nothing was observed to be jammed or stuck.No definitive root cause could be determined for the reported failure.An mre was reviewed, no non-conformances were identified for the reported part 228151- lot 6l36039 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.Device history lot
=
> a manufacturing record evaluation was performed for the finished device [6l36039] number, and no non-conformances 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: 9788175
• MDR Text Key: 206188518
• Report Number: 1221934-2020-00746
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 6L36039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/12/2020
• Patient Sequence Number: 1